The Recall Desk

Archive

September 2014 recalls

675 recalls were announced in September 2014.

What the numbers show

Critical
61
Severe
345
High
167
Moderate
91
Low
11

Of the 675 recalls this month scored against our rubric, 9% are Critical, 51% are Severe.

Which agencies issued them

201–300 of 675

  • HighFDA (Devices)·Z-2610-2014·2014-09-17

    Ethicon Recalls PROXIMATE Skin Staplers Due to Unformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling PROXIMATE skin staplers because a non-conforming component may cause the device to fire an unformed staple.

    Product
    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2426-2014·2014-09-17

    Marjon Bean Sprouts Recalled Due to Listeria Contamination in Production Area

    Marjon Specialty Foods is recalling bean sprouts after Listeria was found in environmental samples from the production area.

    Product
    Marjon Bean Sprouts, Keep Fresh Zip Lock: Keep Refrigerated. NET WT. 8/8 oz. plastic bag; 5 lb bag and 2/5 Bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC codes: 10077554000012; 0200077554000466; 010077554000463 Used by…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2604-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 178 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2014·2014-09-17

    Pioneer Surgical Technology Recalls Streamline MIS Spinal Fixation System Fixed Rod Holders

    Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.

    Product
    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2014·2014-09-17

    Wright Medical Recalls Orthopedic Claw Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling specific orthopedic claw plates because they were manufactured from an incorrect raw material.

    Product
    CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2427-2014·2014-09-17

    Marjon Kale Sprouts Recalled Due to Listeria Contamination in Production Area

    Marjon Specialty Foods is recalling Marjon Kale Sprouts because Listeria was found in environmental samples from the production area.

    Product
    Marjon Kale Sprouts, Keep Refrigerated. NET WT. 6/3 oz. packaged in cups; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2430-2014·2014-09-17

    Hill Country Fare Salsa Con Queso Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Hill Country Fare Salsa Con Queso Sauce due to undeclared wheat, a common allergen.

    Product
    HILL COUNTRY FARE; Salsa Con QUESO Sauce; Medium - PICANTE; NET WT 16 OZ (1LB) CONT. NET. 454g; DISTRIBUTED BY: H-E-B, SAN ANTONIO, TX 78294. distributed in cases of 12/16 oz. jars
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2425-2014·2014-09-17

    Marjon Alfalfa Sprouts Recalled Due to Listeria Contamination Risk

    Marjon Specialty Foods is recalling Marjon Alfalfa Sprouts because environmental samples in the production area tested positive for Listeria.

    Product
    Marjon Alfalfa Sprouts, Pre-Washed Ready to Eat: Keep Refrigerated. NET WT. 6/4 oz. packaged in cups and bags; Marjon Specialty Foods, Inc. 3508 Sydney Rd., Plant City, FL 33567 Grown and Packed in the USA. UPC 20077554000231. Used by 7/06/14.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2600-2014·2014-09-17

    Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 9 units of CLAW 3.5mm plates because they were manufactured from an incorrect raw material.

    Product
    CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2014·2014-09-17

    Life Force Chamber Recalled for Lack of FDA Approval

    Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.

    Product
    Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2014·2014-09-17

    Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure

    Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.

    Product
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2432-2014·2014-09-17

    Hy-Top French Onion Dip Recalled for Undeclared Wheat

    Durrset Amigos, Ltd. is recalling Hy-Top French Onion Dip because a supplier used wheat instead of whey in the cheese premix.

    Product
    HY-TOP FRENCH ONION DIP; NET WT 9 OZ. (255g); DISTRIBUTED BY FEDERATED GROUP, INC.; ARLINGTON HEIGHTS IL. 60005-1096. Shipped in cases of 12/9 oz containers.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2615-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2014·2014-09-17

    Medtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation

    Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.

    Product
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2613-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2014·2014-09-17

    Integra Container Lids Recalled for Lack of FDA Clearance

    Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.

    Product
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2602-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Material Error

    Wright Medical Technology is recalling 1,127 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2014·2014-09-17

    BD MAX MRSA Assay Recalled for False Positive Results

    Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.

    Product
    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2596-2014·2014-09-17

    Primus Medical Recalls Transcend and Bariatric Mattresses Due to Delamination

    Primus Medical LLC is recalling specific Transcend and Bariatric mattresses because the top cover is delaminating. The recall affects 1,557 units distributed in the US and Canada.

    Product
    Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2598-2014·2014-09-17

    Merci Retriever Medical Devices Recalled for Expiration Date Issues

    Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.

    Product
    Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2570-2014·2014-09-17

    CooperSurgical H/S Catheter Recalled Due to Unsealed Pouches

    CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.

    Product
    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2595-2014·2014-09-17

    Catheter Connections Recalls DualCap IV Pole Strips Due to Packaging Seal Defect

    Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.

    Product
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours…
    Category
    Medical Device
    Distribution
    4 states
  • LowFDA (Food)·F-2421-2014·2014-09-17

    Grace Classic Coconut Milk Recalled for Label Misprint

    Grace Foods (USA) Inc is recalling Grace Classic Coconut Milk cans due to a label misprint that incorrectly states no gums, thickeners, or stabilizers were added.

    Product
    Grace Classic Coconut Milk Net 13.5 FL OZ (US) (400 mL) PRODUCT OF THAILAND Packed for: GraceKennedy Limited, 73 Harbour Street Kingston, Jamaica, W.I.
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-1569-2014·2014-09-17

    Chirothin Dietary Supplement Recalled for Unapproved Human Chorionic Gonadotropin

    ChiroNutraceutical LLC is recalling Chirothin dietary supplement bottles because the product contains unapproved human chorionic gonadotropin (hCG) and was marketed without an approved NDA or ANDA.

    Product
    CHIROTHIN Dietary Supplement, 2 Fl Oz (60 ml), OTC. Manufactured for ChiroNeutraceutical, 877-377-7636, Chesterfield, MO 63005.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2594-2014·2014-09-17

    Biomet 3i Healing Abutments Recalled for Incorrect Label Color Coding

    Biomet 3i is recalling 6 units of Bellatek Encode Healing Abutments because the labels have incorrect color coding, though the identifiers are correct.

    Product
    BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
    Category
    Medical Device
    Distribution
    2 states
  • SevereCPSC·14276·2014-09-16

    IKEA Recalls GUNGGUNG Children's Swing Due to Fall Hazard

    IKEA is recalling GUNGGUNG children's swings because suspension fittings can break, causing children to fall. Consumers should remove the swing and return it for a refund.

    Product
    GUNGGUNG child's swing
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V565000·2014-09-15

    Nissan Recalls 2013 Altima Vehicles for Hood Latch Interference

    Nissan is recalling 2013 Altima vehicles because hood latch interference may cause the hood to open while driving, increasing crash risk.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·058-2014·2014-09-12

    Claude's Beef Jerky Recalled for Undeclared Allergens and Lack of Inspection

    Jerky By Art is recalling Claude's Beef Jerky with Red Chile because it was produced without USDA inspection and contains undeclared wheat and anchovies.

    Product
    New Mexico Firm Recalls Beef Jerky Products Produced Without the Benefit of Inspection and Misbranded With Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V562000·2014-09-12

    Mitsubishi Recalls Lancer and Outlander Vehicles for Engine Belt Defect

    Mitsubishi is recalling 2008-2011 Lancer, Lancer Evolution, and Outlander models because the engine drive belt may detach, causing the engine to stall and increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI LANCER SPORTBACK RALLIART, LANCER RALLIART, LANCER RALIART, LANCER SPORTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·057-2014·2014-09-12

    Interbay Food Company Recalls Pork Sausage for Undeclared Milk Allergen

    Interbay Food Company is recalling approximately 4,820 pounds of pork Banger-style sausage because the products contain milk, a known allergen, which is not declared on the label.

    Product
    Interbay Food Company — Washington Firm Recalls Pork Sausage Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V560000·2014-09-12

    Mitsubishi Recalls 2011 Outlander Sport for Brake Booster Defect

    Mitsubishi is recalling certain 2011 Outlander Sport vehicles because a cracked brake booster switch sleeve may prevent the brake pedal from returning, increasing crash risk.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V558000·2014-09-12

    Halcore Recalls 2014 Horton Ambulances with Liquid Spring Suspension Kits

    Halcore is recalling 29 model year 2014 Horton ambulances equipped with Liquid Spring aftermarket suspension kits because the fluid tank mounting bracket may fail.

    Product
    HORTON AMBULANCE — HORTON AMBULANCE 623, 457, 403, 603
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V561000·2014-09-12

    Jayco Recalls 2015 Jay Flight Trailers Due to Ladder Mounting Defect

    Jayco is recalling 2015 Jay Flight 19RD trailers because the roof ladder may be installed on the wrong side without proper support, increasing injury risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V555000·2014-09-11

    Volvo Recalls 2014-2015 Trucks Due to Brake Caliper Bolt Torque Issue

    Volvo is recalling 3,175 model year 2014-2015 VAH, VNL, and VNM trucks because disc brake caliper bolts may not be tightened to specification, increasing crash risk.

    Product
    VOLVO — VOLVO VNM, VAH, VNL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V554000·2014-09-11

    Mack Trucks Recalls 2015 Granite Trucks Due to Fuel Filter Defect

    Mack Trucks is recalling 2015 Granite trucks because a fuel filter defect may cause the engine to stall without warning, increasing the risk of a crash.

    Product
    MACK — MACK GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·14753·2014-09-11

    Arctic Cat Recalls Wildcat Trail Side-by-Sides Due to Fire Hazard

    Arctic Cat is recalling about 5,600 Wildcat Trail and Wildcat Trail XT side-by-side utility vehicles because oil can leak from the oil cooler lines, posing a fire hazard.

    Product
    Arctic Cat Wildcat Trail and Wildcat Trail XT Side by Side
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14275·2014-09-11

    Kidde Recalls Hard-Wired Smoke and Combination Smoke/CO Alarms Due to Failure

    Kidde is recalling about 1.3 million hard-wired smoke and combination smoke/CO alarms because they may fail to alert users during a power outage. No injuries have been reported.

    Product
    Kidde hard-wired smoke and combination smoke/carbon monoxide (CO) alarms
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V556000·2014-09-11

    Toyota Recalls 2014 Tundra CrewMax and Double Cab for Air Bag Defect

    Toyota is recalling 2014 Tundra CrewMax and Double Cab vehicles because a B-pillar trim misinstallation may prevent side air bags from deploying properly in a crash.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V553000·2014-09-11

    Mack Trucks Recalls 2015 Models Due to Seat Belt Bolt Torque Defect

    Mack Trucks is recalling 2015 CHU, CXU, and GU trucks because seat belt bolts may not be torqued correctly, risking detachment in a crash.

    Product
    MACK — MACK GRANITE (GU), CHU, PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V557000·2014-09-11

    Volvo Recalls 2015 VNL and VNX Trucks for Engine Stall Risk

    Volvo is recalling 2015 VNL and VNX trucks because a software error may cause the engine to stall while driving, increasing crash risk.

    Product
    VOLVO — VOLVO VNL, VNX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2486-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling specific lots of EO-sterilized surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Shoulder pack (I) (2), code 900-2515 (1) GOWN IMP. XTRA REINF. XL TOWEL WRAP LEVEL Ill (1) TOWEL ABSORBENT 15" X 20" (1) GOWN XXL SMS IMPERVIOUS REINFORCED (1) MAYO STAND COVER REINFORCED (2) STRIPS TAPE 24" X 4" (1) SUTURE BAG FLORAL (1) SHEET SPLIT W/ADHESIVE 1 08" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2321-2014·2014-09-10

    Customed Recalls Major Lap Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Major Lap Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    MAJOR LAP PACK - (1) TABLE COVER REINF. 50" X 90" 10) GUZE SPONGE 4" X 4" 16PLY XRD (1) DRAPE T LAPAROT 102" X 78" X 121" SMS (1) UTILITY BOWL 32oz (1) TUBE CONNECT. SUCTION W X 12' (1) CAUTERY TIP POLISHER (1) YANKAUER SUCTION TUBE W/0 VENT (4) DRAPE UTILITY WITH TAPE (2)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2453-2014·2014-09-10

    Customed Recalls Vaginal Procedure Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling vaginal procedure packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    VAGINAL PROCEDURE PACK CUSTOM ED CONTENTS: (1) DRAPE LITHOTOMY 110" X 63" W/LEGGINGS I POUCH FEN 3 X 6 SMS LIF (1) GOWN XL SMS IMPERV. REINFORCED LIF (1) COVER MAYO STAND REINFORCED LIF (1) BAG SUTURE FLORAL (1) COVER TABLE REINF 50" X 90" LIF (1) TUBE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2533-2014·2014-09-10

    Customed Recalls Laparoscopy Colorectal Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 280 units of Laparoscopy Colorectal Surgical Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2302-2014·2014-09-10

    Customed Angiodrape Pack Recalled for Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,536 units of Angiodrape Packs due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    Customed Angiodrape Pack convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2360-2014·2014-09-10

    Customed Recalls C-Section Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling C-Section surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    C-SECTION SURGICAL PACK- (1) COVER TABLE REINFORCED 50" X 90" (2) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BABY BLANKET PRINTED (1 0) LAP SPONGES PREWASH 18" X 18" XRD (1) BOWL PLASTIC WITH LID 80oz. (1) BAG GLASSINE (2) NEEDLE & BLADE COUNTER 1 OC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2422-2014·2014-09-10

    Customed Recalls Endoveneous Custom Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 12 lots of Endoveneous Custom Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ENDOVENOUS CUSTOM PACK - CUSTOMED (1) SYRINGE 5cc WITHOUT NEEDLE LUER LOCK L/F (1) Pr. GLOVE SYNTEGRA CR # 7.5 P/F LIF (2) Pr. GLOVE SYNTEGRA CR # 6.5 P/F LIF (20) GAUZE SPONGE 4" X 4" 12PL Y LIF (3) GOWN SMS X-LARGE STD NON REINFORCED ( 1) TABLE COVER 44" X 90" (4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2309-2014·2014-09-10

    Customed Recalls Labor and Delivery Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 3,448 units of Labor and Delivery Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Customed LABOR & DELIVERY PACK - Includes: (1) TABLE COVER 44" x 90" (2) LEGGINS WITH/7" CUFF 30" x 42" (5) ABSORBENT TOWELS 15" x 20" LIF (1) BABY BLANKET PRINTED LIF (2) PAD OBSTETRICAL XLGE LIF (1) EAR ULCER SYRINGE 2oz. LIF (1) BABY BLANKET POLY ABS. IMP. LIF (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2412-2014·2014-09-10

    Puratos Dark Organic Chocolate Chips Recalled for Milk Allergen

    Puratos Chocolate USA is recalling 22,000 lbs of Dark Organic 1M Chip chocolate due to a reported allergic reaction to milk protein.

    Product
    Puratos Chocolante, Dark Organic 1M Chip, Item Number 0065064002SH11, Net Weight: 25 lbs.
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-2320-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 30 lots of EO sterilized Cesarean Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CESAREAN PACK - - (7) TOWELS ABSORBENT 15" X 20" (2) SCALPEL WEIGHTED SAFETY #1 0 (1) BLANKET BABY 30" X 30" POLY ABS IMP (1) BOWL UTILITY QUART 32oz. (1) TUBE FEEDING 8Fr. 15" LONG (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR (1) BEANNIES BABY (2) PAD OBSTRETICAL XLGE ST.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2340-2014·2014-09-10

    Customed Fanfold Drapes Recalled for Potential Packaging Integrity Compromise

    Customed, Inc. is recalling Fanfold Drapes due to potential packaging integrity issues that could compromise sterility and risk patient injury.

    Product
    FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2060-2014·2014-09-10

    Lacteos Santa Martha Fresh Curd Recalled for Listeria Contamination

    Oasis Brands is recalling Lacteos Santa Martha Fresh Curd because a state sample tested positive for Listeria monocytogenes.

    Product
    Lacteos Santa Martha Quesito Casero Fresh Curd Net Weight 12oz Distributed by Oasis Brands Inc., Miami FL 33192
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Devices)·Z-2356-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 273 units of arthroscopy packs across 11 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (2) ABSORBENT TOWELS 15" x 20" LIF (1) TUBE SUCTION CONNECT Y.." X 12' LIF (1) ELASTIC BANDAGE 6" X 5yrd. UF (1) IMPERVIOUS STOCKINETTE 14" X 48" (1) HUCK CLOTH TOWEL WHITE (1) MAYO STAND COVER REINFORCED LIF (1) U DRAPE 60" X70" WITH TAPE SPLIT (4)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2391-2014·2014-09-10

    Customed Recalls Plastic Surgery Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling plastic surgery packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PLASTIC SURGERY PACK - LABEL SAMPLE CONTENTS: (2) GOWN LGE SMS NON REINF T/WRAP L/F (1) MAYO STAND COVER REINF. LIF (10) GAUZE SPONGE 4" X 4" 16 PLY LIF (1) TABLE COVER 44" X 90" (1) DRAPE SHEET 70" X 100" LIF (2) SURGICAL BLADE #15 S/STEEL (1) DRAPE HEAD WIT APE 44" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2304-2014·2014-09-10

    Customed Laparoscopy Convenience Packs Recalled for Packaging Integrity Concerns

    Customed, Inc. is recalling 30 lots of EO sterilized laparoscopy convenience packs because packaging integrity may be compromised, potentially leading to loss of sterility and patient injury.

    Product
    Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. EO…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2529-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Gowns Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EO sterilized surgical gowns because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Gown Impervious , Code 900-3190, contains: GOWN IMPERVIOUS EXTRA LONG X-LARGE WITH TOWEL & WRAP Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2414-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 39 lots of arthroscopy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK- (1) TABLE COVER REINFORCED 50" X 90" (1) PRE PAD WITH CUFF (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (1) GOWN IMPERV. EXTRA REINFORCED LGE TNVRAP (1) MAYO STAND COVER REINFORCED (1) TUBE SUCTION CONNECT. X" X 12' (1) STOCKINETTE IMPERVIOUS 14" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2427-2014·2014-09-10

    Customed Recalls O.B. Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling O.B. Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    O.B. PACK - ( I) PVP SCRUB 8" STICK SPONGES ( I) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" ( I) DRAPE ABDOMINAL WITH TAPE LIF ( I) VAGINAL PACKING SPONGEXRD ( I) BOWL WITH LID PLASTIC 80oz ( I) RECEIVING BLANKET 100% COTTON (I) BABY BLANKET POLY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2484-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed is recalling specific lots of HIP PACK I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    HIP PACK I (2), CUSTOMED, code 900-2504 (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP (1) MAYO STAND COVER REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (1) STOCKINETTE IMPERVIOUS 12" X 48" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE HIP 89" X 128"…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2500-2014·2014-09-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 74 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Shoulder Arthroscopy Pack, code 900-2719, contains: (1 0) GAUZE SPONGES 4 X 4 12PL Y (1) COBAN WRAP TAN 4 X 5yds (3) PAD ABDOMINAL 8 X 7.5 (1) DRESSING 1 X 8 XEROFORM PETROLAT (1 0) GAUZE SPONGES 4 X 4 16PL Y XRD (1) NEEDLE HYPODERMIC 18G X 1 (1) NEEDLE SPINAL ANESTH 18G…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2498-2014·2014-09-10

    Customed Recalls Endovascular Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Endovascular Packs (code 900-2715) because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Endovascular Pack, code 900-2715, contains: ( I) DRAPE FEMORAL ANG. 125 X 75 X 56 WITH POUCH LIF (2) TOWELS ABSORBENT 15 X 20 LIF ( I) CONTAINER SPECIMEN 4oz W/LID & LABEL Llf (2) BAG BAND FLUOROSCOPE 36 X 30 LIF ( I) NEEDLE HYPODERMIC 21G X I Y, LIF (2) GOWN LARGE SMS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2481-2014·2014-09-10

    Customed Recalls Shoulder Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 114 units of Shoulder Packs (Code 900-2616) because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 NDL UL UF (2) DRAPE VIDEO CAMERA UF (1) COVER MAYO STAND REINF. UF (5) SPONGE LAP. PRE-WASH XRD UF (1) DRAPE U 60" X 70" WIT APE UF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2471-2014·2014-09-10

    Customed Recalls EENT Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling EENT surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EENT PACK I CUSTOMED CONTENT: (2) TOWEL ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) BAG SUTURE FLORAL (1) SHEET ENT SPLIT 110" X 77" SMS (1) TABLE COVER REINFORCED 50" X 90" (1) DRAPE HEAD W!TAPE 44" X 26" (1) GOWN SURG. REINFORCED XLGE TOWEL/WRAP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2346-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,041 units of EO sterilized surgical convenient packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2446-2014·2014-09-10

    Customed Recalls Central Line Full Body Drapes Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Central Line Full Body Drapes because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CENTRAL LINE FULL BODY DRAPE CUSTOMED CONTENTS: (1) WRAPPER 30" X 30" (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS (1) DRAPE BRACHIAL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2381-2014·2014-09-10

    Customed Recalls Premium Ophthalmic Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 720 units of Premium Ophthalmic Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PREMIUM OPHTHALMIC PACK- CUSTOMED- (1) GOWN SMS X-LARGE STD RAGLAN (1) CUP MEDICINE 2oz (1) DRAPE OPHTHAL. WITH POUCH LIF (1 0) SPONGE EYE SPEAR MICRO (1) SHIELD EYE UNIVERSAL (6) COTTON TIP APPLICATION 6" WOOD LIF (1 0) GAUZE SPONGES 4"X 4" 12PL Y (2) TOWELS ABSORBENT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2456-2014·2014-09-10

    Customed Recalls Extremity Arm Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 112 units of Extremity Arm Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    EXTREMITY ARM PACK CONTENTS: (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) GOBAN SELF-ADHERENT WRAP 6" X 5yds (3) BANDAGE ELASTIC 4" X 5yds (1) BANDAGE ESMARK 6" X 9 (1) UTILITY BOWL QUART 32oz (10) GAUZE SPONGE 4" X 4" 16PLY (1) TUBE SUCTION CONNECTX 12' (1)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2504-2014·2014-09-10

    Customed Recalls Neuro Spine Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Neuro Spine Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    NEURO SPINE PACK , CODE 900-2765 CONTENTS: (l ) DRAPE INCISION 23" X 1 7" (I) SCALPEL W/HANDLE # 15 S/STEEL (I) INSTRUMENT POUCH 7 X 1 1 2 COMPART (I) Pk. STRIP SURGICAL W' X 6" (I) CAUTERY PENCIL HAND SWITCHING LIF (4) UTILITY DRAPE W/TAPE L/F (I)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2335-2014·2014-09-10

    Customed Recalls Laparoscopy Gyn Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,136 units of Laparoscopy Gyn Packs across 34 lots because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROSCOPY GYN PACK - - (1) BLADE SURGICAL #11 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOWEL 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (1) TOWEL CLOTH HUCK BLUE (1) BLADE SURGICAL #15 CARBON STEEL (2) UTILITY BOWL 16oz (1) UTILITY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2336-2014·2014-09-10

    Customed Recalls Angiography Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 1,305 units of angiography packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ANGIOGRAPHY PACK - ( 1) FEMORAL ANGlO. DRAPE WITH POUCH (2) SYRINGE 10cc W/0 NEEDLE LUER LOCK LIF (2) NEEDLE HYPODERMIC 21G X 1% ( 1) TABLE COVER REINFORCED 44" X 78" LIF (30) GAUZE SPONGES 4" X 4" 12PLY ( 1) GOWN IMPERVIOUS REINFORCED LARGE SMS ( 1) GOWN LARGE NON…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2353-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,300 laparotomy packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK - CONTENTS: ( 1) GOWN XL SMS IMPERVIOUS REINFORCED LIF ( 1) MAYO STAND COVER REINFORCED LIF (1) BAG SUTURE FLORAL LIF (4) DRAPE UTILITY WITH TAPE LIF (2) DRAPE SHEET 41 II X 58" SMS L/F ( 1) TABLE COVER 50" X 90" LIF ( 1) SOLUTION SURGICAL DURAPREP 26ML…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2384-2014·2014-09-10

    Customed Recalls Premium Laparotomy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Premium Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2461-2014·2014-09-10

    Customed Recalls Basic Pack 1 Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Basic Pack 1 surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    BASIC PACK 1 (Ill) CUSTOMED CONTENTS: (1) TABLE COVER REINFORCED 44" X 78" (4) DRAPE UTILITY WffAPE (2) TOWELS ABSORBENT 15" X 20" (1) SUTURE BAG FLORAL (1) DRAPE SHEET 42" X 57" SMS (1) SHEET :X 57" X 63" REINFORCED SMS (1) MAYO STAND COVER REINFORCED Product Usage…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2477-2014·2014-09-10

    Customed Recalls EO Sterilized Surgical Gown Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 20 lots of EO sterilized surgical gown packs because packaging integrity may be compromised, potentially leading to loss of sterility.

    Product
    Gown Cool Impervious XLGE Breathable Customed, 900-2592: (1) GOWN XL SURGICAL MICROCOOL (1) WRAPPER 24" X 24" (1) TOWELS ABSORBENT 15" X 20" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2502-2014·2014-09-10

    Customed Recalls Surgical Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 208 units of surgical packs for knee and hip replacements because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2470-2014·2014-09-10

    Customed Recalls Laparotomy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,233 units of EO sterilized surgical laparotomy packs because packaging integrity may be compromised, risking product contamination or loss of sterility.

    Product
    LAPAROTOMY PACK Ill (4) CUSTOMED CONTENT: (4) TOWEL ABSORBENT 15" X 20" (2) GOWN XLARGE SMS IMPERVIOUS REINFORCED (1) COVER MAYO STAND REINFORCED (2) DRAPE SHEET 41" X 58" SMS (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) DRAPE T LAPAROTOMY 102" X 78" X…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2380-2014·2014-09-10

    Customed Recalls OB Packs Due to Potential Packaging Integrity Compromise

    Customed, Inc. is recalling OB Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OB PACK - (2) EXAM GLOVES MED. (1 0) GAUZE SPONGES 4" X 4" 12PL Y (2) LEGGINS W/ 7" CUFF (2) DRAPE SHEET SMS (1) ABDOMINAL DRAPE W/TAPE (1) PLASTIC BOWL W/Lid 70 oz. (1) EAR/ULCER SYRINGE 2oz. L/Free (1) UMBILICAL CORD CLAMP (1) BABY BEANNIES (1) PVP SCRUB 8" STICK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2430-2014·2014-09-10

    Customed Recalls Cesarean Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 420 units of EO-sterilized Cesarean Packs because packaging integrity may be compromised, posing a risk of product contamination or loss of sterility.

    Product
    CESAREAN PACK - (1) BABY BLANKET IMP. POLY ABS. (4) ABSORBENT TOWELS 15" x 20" LIF (2) NEEDLE & BLADE COUNTER 10C MAG/CLEAR LIF (2) LITE GLOVES LIF (1) BOWL PLASTIC WITH LID 80 oz. (1) C-SECTION DRAPE W/ POUCH 102" X 121 " X 78" (1) UTILITY BOWL 32 oz. (10) LAP…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2338-2014·2014-09-10

    Customed Recalls Arthroscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 2,620 units of Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) TUBE SUCTION CONNECTING X" X 12' LIF (1) IMP. STOCKINETTE (1) SURGICAL BLADE #11 STAINLESS STEEL (1) ANESTHESIA SPINAL NEEDLE 18G X 3 ~ (1) SYRINGE Sec WITH NEEDLE 21G X 1 ~…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2377-2014·2014-09-10

    Customed Recalls Laparoscopy Packs Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 21 lots of Laparoscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    LAP AROSCOPY PACK - (10) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF (1) MAYO STAND COVER REINFORCED L/F (4) ADHESIVE BANDAGE%" X 3" ST. LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (2) GOWN IMPERVIOUS REINFORCED LARGE SMS (2) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE LASER CAMERA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2419-2014·2014-09-10

    Customed Recalls AV Fistula Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling AV Fistula surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2386-2014·2014-09-10

    Customed Recalls Premium Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Premium Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    PREMIUM ARTHROSCOPY PACK - CUSTOMED- (1) ARTHROSCOPY SHEET T WITH POUCH LIF (1) IMPERVIOUS STOCKINETTE (3) STRIPS TAPE 24" X 4" (1) DRAPE U WITH TAPE SPLIT (2) TOWELS ABSORBENT 15" X 20" LIF (1) GOWN IMPERVIOUS REINFORCED X-LARGE SMS (1) GOW SURG. REINFORCED LARGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2530-2014·2014-09-10

    Customed Recalls Breast Surgical Packs Due to Potential Sterility Loss

    Customed is recalling breast surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Breast pack TPSC, code 900-3431, contains: (1) GOWN LARGE STANDARD SMS AAMIIII (1) GOWN SOFT SMS STD. X-LARGE AAMIIII (4) TOWELS ABSORBENT 15" X 20" LIF (1) PENCIL CAUTERY PUSH BOTTOM LIF (1) SYRINGE 60ML LUER LOCK WITHOUT NEEDLE L/F (1) TUBE SUCTION CONNECT X" X 12' LIF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2389-2014·2014-09-10

    Customed Recalls Open Heart Surgical Trays Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Open Heart Surgical Trays because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2409-2014·2014-09-10

    Customed Recalls Minor Laparotomy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Minor Laparotomy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    MINOR LAPAROTOMY PACK - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) GOWN SURG. X-LARGE REINFORCED TOWEL/WRAP (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED LIF (3) TOWELS ABSORBENT 15" X 20" LIF (1) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) COUNTER NEEDLE & BLADE 10C…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2349-2014·2014-09-10

    Customed Recalls Carpal Tunnel Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling carpal tunnel surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CARPAL TUNNEL SURGICAL LARGE PACK (1) COVER TABLE 44" X 90" LIF (1) NEEDLE HYPODERMIC 18G X 1 % LIF (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) BOWL UTILITY QUART 32oz. (2) SHEET DRAPE 41" X 58" SMS LIF (2) TOWELS ABSORBENT 15" X 20" LIF (1) BANDAGE GAUZE STRETCH…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1575-2014·2014-09-10

    Apotex Recalls PAXIL Oral Suspension Due to Chemical Contamination

    Apotex Inc. is recalling PAXIL (Paroxetine HCL) Oral Suspension because it was manufactured with active pharmaceutical ingredient batches contaminated with residual materials and solvents.

    Product
    PAXIL (Paroxetine HCL) Oral Suspension 10 mg/5 mL - 250 mL bottle, Rx Only, Manufactured by GlaxoSmithKline, RTP, NC 27709. Distributed by Apotex Corp., Westin, FL 33326, NDC 60505-0402-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2472-2014·2014-09-10

    Customed Recalls Orthopedic Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Orthopedic Pack I surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2524-2014·2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Tummy Tuck surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Tummy Tuck Pack- FJG, code 900-3114, contains: (2) GOWN LARGE SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWEL ABSORBENT 15" X 20" (1) PENCIL CAUTERY PUSH BOTIOM ST. HOLSTER (1) NEEDLE HYPODERMIC 22G X 1 Y2 (2) SYRINGE 20CC WITHOUT NEEDLE LUER LOCK (1) COUNTER NEEDLE & BLADE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2518-2014·2014-09-10

    Customed Recalls Tummy Tuck Surgical Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Tummy Tuck Pack-BOD surgical packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Tummy Tuck Pack-BOD , code 900-3026, contains: (2) GOWN X-LARGE SMS IMPERVIOUS REINFORCED AAMIIII (2) TOWELS ABSORBENT 15 X 20 (1) PENCIL CAUTERY PUSH BOTTOM (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) BOWL UTILITY QUART 32oz TURQ (1) COVER MAYO STAND REINFORCED (2) SKIN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2433-2014·2014-09-10

    Customed Recalls Open Heart Surgical Tray Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling Open Heart Tray Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2357-2014·2014-09-10

    Customed Recalls Curation Kits Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling 16 lots of Curation Kits because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    CURATION KIT - CUSTOMED- (10) GAUZE SPONGE 4" X 4" 16PL Y (4) ABSORBENT TIP APPLICATOR (4) PVP PREP SOLUTION 1 oz (1) CONTAINER SPECIMEN 4oz WITH LID & LABEL (2) EXAM GLOVES MEDIUM (1) WRAPPER 24" X 24" UF (1) PACKING TRAY EO sterilized surgical convenient packs…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2519-2014·2014-09-10

    Customed Recalls Face Pack BOD Due to Potential Packaging Integrity Issues

    Customed, Inc. is recalling Face Pack BOD units because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    Face Pack- BOD, code 900-3027, contains: (2) GOWN XL SMS IMPERVIOUS REINFORCED AAMI Ill (2) TOWELS ABSORBENT 15" X 20" (1 ) DRAPE INSTRUMENT MAGNETIC 10" X 16" (1 ) TRAY HALF DEEP (1) COUNTER NEEDLE/BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1 ) SHEET ENT SPLIT…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2439-2014·2014-09-10

    Customed Recalls Shoulder Arthroscopy Packs Due to Packaging Integrity Concerns

    Customed, Inc. is recalling 1,707 units of Shoulder Arthroscopy Packs because packaging integrity may be compromised, potentially leading to product contamination or loss of sterility.

    Product
    SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE SHEET 70" X 100" (1) GOWN SURG REINFORCED XLGE T/WRAP (1) NEEDLE SPINAL ANESTH. 18G X 3ST. (1) STOCKINETTE 6 X 48" (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK (1) SCALPEL…
    Category
    Medical Device
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.