The Recall Desk

Archive

September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical
119
Severe
574
High
366
Moderate
102
Low
25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 48% are Severe.

Which agencies issued them

701–800 of 1186

  • ModerateFDA (Devices)·Z-2749-2015·2015-09-16

    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN Recalled for Punctured Packaging

    Elcam Medical is recalling MANI 3G Plate BLS RAD B.BRAUN manifolds because punctured blister packages were detected during manufacturing, creating a potential for device contamination.

    Product
    Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., USA. Sterile
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Food)·F-3089-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Cherries for Elevated Microbial Counts

    Coloma Frozen Foods is recalling IQF Red Tart Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.

    Product
    IQF Red Tart Cherries, 30 lbs., 2/5 lb packages/case, 4/5 lb. packages per case; packed in cartons, square plastic pails, and poly bag in cartons; Nature Blessed Red Tart Cherries, 4/40 oz. packages per case.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1420-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.

    Product
    Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-368-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1427-2015·2015-09-16

    Healthpoint Recalls Surgicept Surgical Hand Scrub Due to Chemical Contamination

    Healthpoint, Ltd is recalling 11,910 bottles of Surgicept surgical hand scrub because a naphthalene compound was identified in the product.

    Product
    Surgicept (Ethyl alcohol 70% w/w) WATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash in 1150 mL bottles. MARKETED BY: CafeFusion, Leawood, KS 66211, MANUFACTURED FOR: HEALTHPOINT, LTD Ft. Worth, Texas 76107, MANUFACTURED BY: DPT LABORATORIES, LTD 3300 Research Plaza…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2737-2015·2015-09-16

    Mindray DPM 7 Patient Monitors Recalled for Black Screen Display

    Mindray is recalling 13 DPM 7 patient monitors because they may display a black screen, potentially preventing the display of patient data.

    Product
    Mindray DPM 7 Monitor, Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2740-2015·2015-09-16

    DermaPen Pro Micro Needling System Recalled for Lack of FDA Clearance

    Derma Pen, LLC is recalling DermaPen Pro Micro Needling Systems because the devices were distributed without FDA clearance or approval.

    Product
    DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical instrument for dermabrasive use. Each motorized handpiece is packaged within a small box. Each disposable needle cartridge is packaged individually and then placed into boxes of 30 quantities per box.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2744-2015·2015-09-16

    Biomet C-Tek Maxan Anterior Cervical Plate System Mislabeled Recall

    Biomet Spine is recalling 7 parts of the C-Tek Maxan Anterior Cervical Plate System because some units were mislabeled with an incorrect part number.

    Product
    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1425-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling Imipramine HCl tablets because benzophenone leached from the label varnish. The recall covers 10,080 bottles distributed nationwide.

    Product
    Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-914-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1423-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Benzophenone Contamination

    Mutual Pharmaceutical is recalling 5,472 bottles of Imipramine HCl 10 mg tablets because benzophenone leached from the label varnish.

    Product
    Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 54738-912-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3090-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Pitted Cherries for Elevated Mold Counts

    Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration with elevated mold, yeast, and coliform counts.

    Product
    Red Tart Pitted Cherries, 5 Parts Fruit and 1 Part Sugar, 30 lbs. bulk pails, 15 lbs, in bulk pails
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2739-2015·2015-09-16

    Siemens ADVIA Centaur Folate Diluent Recalled for Low Recovery Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate Ascorbic Acid Diluent because it causes low red blood cell control recoveries and low patient sample results.

    Product
    ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-3091-2015·2015-09-16

    Coloma Frozen Foods Recalls Red Tart Pitted Cherries Due to Microbial Counts

    Coloma Frozen Foods is recalling Red Tart Pitted Cherries due to potential adulteration from elevated mold, yeast, and coliform counts.

    Product
    Red Tart Pitted Cherries, Straight Packed (No Sugar), 5 lbs. bulk pails, 30 lbs, in bulk pails
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2736-2015·2015-09-16

    Medtronic Perfusion Tubing Packs Recalled for Low Ultrafiltration Performance

    Medtronic is recalling specific perfusion tubing packs and hemoconcentrators because they demonstrate low ultrafiltration performance below product specifications.

    Product
    MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators). Model # 7U65R2, 8C72R4, 6N21R2, BB7M38R11, TL2Q68R17, HY8R66R3, HY2U43R9, 8C72R4, BB5J59R19, 6B65R3, TL7M46R7, TL2Q68R17, 7U65R2, M074704B, M230002A, BB7M38Rll, M450013B, BB8N86R4, HY2U43R9…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2759-2015·2015-09-16

    Biomet Spine Lineum OCC Starter Flexible Instruments Recalled for Design Control Issues

    Biomet Spine is recalling Lineum OCC Starter Flexible instruments because they were distributed before design control activities were completed.

    Product
    Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1421-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the product label varnish.

    Product
    Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co. Inc., Philadelphia, PA --- NDC 53489-369-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1422-2015·2015-09-16

    Mutual Pharmaceutical Recalls Felodipine Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Felodipine Extended-Release Tablets because benzophenone leached from the label varnish.

    Product
    Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1424-2015·2015-09-16

    Mutual Pharmaceutical Recalls Imipramine HCl Tablets Due to Chemical Contamination

    Mutual Pharmaceutical is recalling specific lots of Imipramine HCl tablets because benzophenone leached from the label varnish.

    Product
    Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmaceutical Co., Inc., Philadelphia, PA --- NDC 54738-913-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1419-2015·2015-09-16

    CVS Sugar Free Black Cherry Cough Drops Recalled for Foreign Tablets

    Bestco, Inc. is recalling CVS Sugar Free Black Cherry Cough Drops because they may contain comingled Sugar Free Honey Lemon cough drops.

    Product
    CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25 Drop Bags (UPC: 050428 448526) and b) 36 drop bags (UPC: 050428 476581), Over the Counter. Distributed by: CVS Pharmacy, Inc., One CVS Drive Woonsocket, RI 02895.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1426-2015·2015-09-16

    FDA Recalls Methocarbamol Tablets Due to Presence of Hair

    Golden State Medical Supply Inc. is recalling 1,165 bottles of Methocarbamol 500 mg tablets because they contain hair.

    Product
    METHOCARBAMOL TABLETS, USP 500 mg, 500 Count Bottles, Rx Only. Manufactured by AustarPharma LLC, Edison, NJ 08837, USA, Packaged by GSMS Incorporated, Camarillo, CA 93012, USA, NDC: 60429-118-05.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1418-2015·2015-09-16

    Oasis Medical Recalls ImproVue Ophthalmic Drops for pH Specification Failure

    Oasis Medical is recalling 909 cartons of ImproVue Ophthalmic Lubricant Drops due to a failure to meet pH specifications. The affected lot was distributed in Florida.

    Product
    ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·15V574000·2015-09-15

    Honda Recalls 2014-2015 Civic and Fit for Transmission Software Defect

    Honda is recalling 2014-2015 Civic and 2015 Fit vehicles to update transmission software that may damage the drive pulley shaft, potentially causing loss of acceleration or wheel lockup.

    Product
    HONDA — HONDA FIT, CIVIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15754·2015-09-15

    Segway Recalls Off-Board Chargers for Personal Transporters Due to Shock Hazard

    Segway is recalling approximately 17 off-board chargers for its Personal Transporters because a wire can detach and cause an electric shock. No injuries have been reported.

    Product
    Off-Board Charger for Segway Personal Transporter (PT)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15E075000·2015-09-15

    Old World Recalls Peak Lithium Jump-Starters Due to Overheating Risk

    Old World Industries is recalling specific Peak Lithium Rechargeable Jump-Starters because the lithium battery may overheat, increasing the risk of fire.

    Product
    ELECTRICAL SYSTEM:12V/24V/48V BATTERY recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V572000·2015-09-14

    McNeilus Trucks Recalled for Defective Fire Extinguishers

    McNeilus is recalling 2013-2015 concrete mixers and refuse trucks because the installed fire extinguishers may fail to discharge, increasing injury risk during a fire.

    Product
    MCNEILUS — MCNEILUS REAR LOADER, XXC REAR LOADER, ATLANTIC FRONT LOADER, STANDARD MIXER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V570000·2015-09-11

    Triple E Unity Motorhomes Recalled for Battery Gas Leak Risk

    Triple E is recalling 2015-2016 Unity motorhomes because the battery compartment was not properly sealed, allowing explosive gases to enter the vehicle and increasing fire risk.

    Product
    TRIPLE E — TRIPLE E UNITY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·15V571000·2015-09-11

    Land Rover Recalls 2014 Range Rover Sport for Air Bag Handbook Error

    Jaguar Land Rover is recalling 5,914 vehicles because the owner's handbook incorrectly describes the Air Bag Status Indicator Lamp, potentially increasing injury risk in a crash.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V568000·2015-09-10

    Hyundai Recalls 2011-2012 Sonata Vehicles for Engine Crankshaft Defect

    Hyundai is recalling 2011-2012 Sonata vehicles because metallic debris in the engine crankshaft may restrict oil flow, potentially causing engine failure and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·122-2015·2015-09-10

    Pork Rind Factory Recalls Pork Rinds Due to Undeclared Allergens

    The Pork Rind Factory is recalling approximately 18,406 pounds of pork rinds because they contain undeclared milk and soy allergens.

    Product
    The Pork Rind Factory — The Pork Rind Factory Recalls Pork Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    4 states
  • HighCPSC·15242·2015-09-10

    Philips Recalls Halogen Bulbs Due to Laceration and Burn Hazards

    Philips is recalling about 370,000 halogen bulbs because the lens can shatter, posing laceration and burn risks. Consumers should stop using them and contact Philips for a free replacement.

    Product
    Halogen Bulbs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V567000·2015-09-10

    Entegra Motorhomes Recalled for Exhaust Tube Fire Risk

    Entegra is recalling 2010 Anthem and 2012-2014 Cornerstone motorhomes because a flexible exhaust tube may tear, allowing hot exhaust to contact other components and increase fire risk.

    Product
    ENTEGRA — ENTEGRA CORNERSTONE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E074000·2015-09-10

    Reese Explore Bike Carriers Recalled for Cradle Failure Risk

    Cequent is recalling specific Reese Explore Bike Carriers because incorrectly molded cradles may rip and fail, causing bicycles to fall off the rack.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3059-2015·2015-09-09

    Mahina Mele Farm Recalls Salted Macadamia Nuts Due to Salmonella

    Mahina Mele Farm is recalling salted macadamia nuts after an FDA sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.

    Product
    Izzie Macs! Macadamia Nuts; Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 6 oz. and 16 oz sizes. 6 oz, UPC 689076792677; 16 oz. UPC 689076792974 Mahina Mele Farm, Captain Cook, HI 96704
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-3063-2015·2015-09-09

    Mahina Mele Farm Recalls Chocolate Mac Nut Butter Due to Salmonella

    Mahina Mele Farm is recalling Baby Bruddah's Chocolate Mac Nut Buttah because an ingredient sample tested positive for Salmonella.

    Product
    Baby Bruddah's Chocolate Mac Nut Buttah. 12 oz. container, UPC 735182242040 Mahina Mele Farm, Captain Cook, HI 96704
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-3060-2015·2015-09-09

    Mahina Mele Farm Recalls Macadamia Nuts Due to Salmonella Risk

    Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella. Consumers should stop eating the product and return it to the store.

    Product
    Izzie Macs! Macadamia Nuts; Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 6 oz. and 16 oz sizes. 6 oz, UPC 689076793575; 16 oz. UPC 689076792776 Mahina Mele Farm, Captain Cook, HI 96704
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-3062-2015·2015-09-09

    Mahina Mele Farm Recalls Mac Nut Butter Due to Salmonella

    Mahina Mele Farm is recalling Baby Bruddah's Mac Nut Buttah because an ingredient sample tested positive for Salmonella.

    Product
    Baby Bruddah's Mac Nut Buttah. 12 oz. container, UPC 753182242019 Mahina Mele Farm, Captain Cook, HI 96704
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-3061-2015·2015-09-09

    Mahina Mele Farm Recalls Macadamia Nuts Due to Salmonella

    Mahina Mele Farm is recalling Izzie Macs! Macadamia Nuts because an inspection sample tested positive for Salmonella.

    Product
    Izzie Macs! Macadamia Nuts; salted and unsalted pieces. Certified Organic Macadamia Nuts, 100% Big Island Grown. A Raw Food. sold in 5 lb. bag; Mahina Mele Farm, Captain Cook, HI 96704
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-3076-2015·2015-09-09

    Good Seed Recalls Mung Bean Sprouts Due to Listeria Risk

    Good Seed, Inc. is voluntarily recalling mung bean sprouts due to potential Listeria monocytogenes contamination. The products were distributed to retail stores in Virginia, Maryland, and New Jersey.

    Product
    Mung Bean sprouts, 1, 2 & 10-lb clear plastic bags labeled GOODSEED Mung Bean Sprouts, Keep Refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1414-2015·2015-09-09

    Bi-Est Cream Recalled for Potential Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling Bi-Est cream due to potential penicillin cross contamination. The recall covers 36 prescriptions distributed nationwide.

    Product
    Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2560-2015·2015-09-09

    Customed Arthroscopy Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 45 Arthroscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ARTHROSCOPY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2558-2015·2015-09-09

    Customed Cysto TUR Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 290 packs of Cysto TUR Pack due to inadequate validation of sterilization processes and package integrity.

    Product
    CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2676-2015·2015-09-09

    Customed Gauze Sponges Recalled for Sterilization Process Validation Issues

    Customed, Inc. is recalling 19,328 units of 4"x4" 16-ply gauze sponges distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    GAUZE SPONGE 4"X4" 16 PLY SOFT 1280/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1338-2015·2015-09-09

    Leucovorin Calcium Capsules Recalled for Potential Penicillin Contamination

    South Coast Specialty Compounding is recalling Leucovorin Calcium capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.

    Product
    Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2697-2015·2015-09-09

    Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2545-2015·2015-09-09

    MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

    Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.

    Product
    MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2707-2015·2015-09-09

    Customed Cesarean PK 4/CS Recalled for Sterilization Validation Defects

    Customed, Inc. is recalling 48 units of CESAREAN PK 4/CS surgical kits due to inadequate validation of sterilization processes and package integrity.

    Product
    CESAREAN PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2527-2015·2015-09-09

    Recall of Mahurkar Acute Dual Lumen Catheter Trays Due to Sterility Concerns

    Covidien LLC is recalling 8 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow¿ Pre-Curved with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135139 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2546-2015·2015-09-09

    MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

    Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could cause burns or reduced therapy.

    Product
    MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2655-2015·2015-09-09

    Customed Suction Catheter Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 8,300 suction catheter kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    SUCTION CATHETER KIT CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2536-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise

    FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.

    Product
    MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2534-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3078-2015·2015-09-09

    Chetak Recalls Deep Coriander Powder Due to Salmonella Risk

    Chetak New York is recalling 300 jars of Deep Coriander Powder because they may be contaminated with Salmonella.

    Product
    Deep All Natural Spices Coriander Powder, Net Wt 400g/14.1 oz Product of India, Distributed by: Chetak New York, L.L.C. Edison, NJ 08837 USA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2537-2015·2015-09-09

    Recall of Mahurkar Acute Dialysis Catheters Due to Sterility Concerns

    Covidien LLC is recalling 550 kits of Mahurkar 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Straight Extensions, PASS Tray Item Code: 8888104003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2535-2015·2015-09-09

    MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise

    Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.

    Product
    MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3082-2015·2015-09-09

    Westbrook's Cannery Recalls Horseradish Dill Pickles Due to Underprocessing

    Westbrook's Cannery is recalling 16-ounce jars of Horseradish Dill Pickles because the products may be underprocessed. Consumers in 11 states should stop using the product.

    Product
    WESTBROOK'S CANNERY HORSERADISH DILL PICKLES, Net WT. 16 oz (453.592G) glass jars, Ingredients: Cucumbers, White Distilled Vinegar, Water, Pickling Salt, Horseradish, Garlic Cloves, Dill Seed, Dill Weed, Alum 221 West Third Street - Zoar, OH 44697 www.wesbrookscannery.com UPC 8…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1409-2015·2015-09-09

    Estradiol and Estriol Capsules Recalled for Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling Estradiol and Estriol capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.

    Product
    Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3064-2015·2015-09-09

    Good Seed Recalls Soybean and Mung Bean Sprouts for Listeria Risk

    Good Seed, Inc. is voluntarily recalling soybean and mung bean sprouts due to potential Listeria monocytogenes contamination.

    Product
    Soybean sprouts, 1, 2 & 10-lb clear plastic bags labeled GOODSEED Soy Bean Sprouts Keep Refrigerated
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2488-2015·2015-09-09

    Synthes Recalls VEPTR Inferior Cradles Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling VEPTR Inferior Cradles because a partially formed hole may cause mechanical failure, potentially requiring surgery.

    Product
    VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1415-2015·2015-09-09

    Bi-Est and Progesterone Vaginal Suppositories Recalled for Penicillin Contamination

    South Coast Specialty Compounding is recalling Bi-Est and Progesterone Vaginal Suppositories due to potential penicillin cross-contamination.

    Product
    Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1407-2015·2015-09-09

    South Coast Specialty Compounding Recalls Tri-Est 80:10:10 Capsules

    South Coast Specialty Compounding is recalling Tri-Est 80:10:10 capsules due to potential penicillin cross-contamination. The affected products were distributed nationwide.

    Product
    Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1410-2015·2015-09-09

    Bi-Est Hormone Drops Recalled for Potential Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling five prescriptions of Bi-Est hormone drops due to potential penicillin cross contamination.

    Product
    Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3081-2015·2015-09-09

    Westbrook's Dilly Beans Recalled for Potential Underprocessing

    Westbrook's Cannery is recalling 12-ounce jars of Dilly Beans because they may be underprocessed. The product was distributed to 11 states.

    Product
    West brook's Dilly Beans, Net WT. 12 oz (354.882g) glass jars, Ingredients: White Distilled Vinegar, Water, Green Beans, Alum, Pickling Salt, Spices 330-874-8120 www.wesbrookscannery.com UPC 8 53238 00440 7
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-2517-2015·2015-09-09

    Halyard Health Recalls KimVent Multi-Access Port Replacement Catheters

    Halyard Health is recalling KimVent Multi-Access Port Replacement Catheters because the thumb valve may remain partially open after suctioning, potentially compromising the closed suction system.

    Product
    KimVent* Multi-Access Port Replacement Catheter for Adults,Tracheostomy, 14 F (Product Code 2401453-5) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2710-2015·2015-09-09

    Customed Curations Kits Recalled Due to Sterilization Validation Issues

    Customed, Inc. is recalling Curations Kits in Puerto Rico because the sterilization process and package integrity were not adequately validated.

    Product
    CURATION KIT 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2684-2015·2015-09-09

    Customed Surgical Gowns Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling surgical gowns due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.

    Product
    SURG GOWN POLYREINF LGE CUSTOM 28/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2526-2015·2015-09-09

    Mahurkar Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 96 kits of Mahurkar Acute Dual Lumen Catheter Trays because sterility may be compromised.

    Product
    Mahurkar Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 FR x 13.5 cm Item Code: 8888135137 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1337-2015·2015-09-09

    Bi-Est 80:20 Progesterone Capsules Recalled for Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling Bi-Est 80:20 Progesterone capsules due to potential penicillin cross-contamination.

    Product
    Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2589-2015·2015-09-09

    Customed D & C Laparoscopy Packs Recalled for Sterilization Defects

    Customed, Inc. is recalling 192 D & C Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    D & C LAPAROSCOPY PK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1342-2015·2015-09-09

    Methyl Folate Injection Recalled Due to Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling Methyl Folate Injection vials due to potential penicillin cross-contamination. The recall covers 335 vials distributed nationwide.

    Product
    Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1339-2015·2015-09-09

    Meloxicam Capsules Recalled for Potential Penicillin Cross Contamination

    South Coast Specialty Compounding is recalling Meloxicam 12 mg capsules due to potential penicillin cross contamination. The recall covers all lots expiring in August 2015.

    Product
    Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving, CA -non-sterile formulation
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2692-2015·2015-09-09

    Customed Recalls Laparoscopy-Gyn Surgical Packs Due to Sterilization Issues

    Customed, Inc. is recalling 84 units of Laparoscopy-Gyn Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    LAPAROSCOPY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2615-2015·2015-09-09

    Customed Endoveneous Custom Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 20 units of Endoveneous Custom Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    ENDOVENOUS CUSTOM PACK 5/CS CUSTOMED Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2688-2015·2015-09-09

    Customed Recalls Lap-Cholecystectomy Surgical Packs Due to Sterilization Issues

    Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.

    Product
    LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2533-2015·2015-09-09

    Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns

    Covidien LLC is recalling 165 Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised. The affected units were distributed nationwide.

    Product
    Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 13 cm Item Code: 8888233413 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2015·2015-09-09

    FDA Recalls Estriol and Estradiol Cream Due to Penicillin Contamination

    South Coast Specialty Compounding is recalling 61 prescriptions of Estriol and Estradiol cream because the products may be contaminated with penicillin.

    Product
    Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1341-2015·2015-09-09

    FDA Recalls Chorionic Gonadotropin Injectable Due to Penicillin Contamination

    South Coast Specialty Compounding is recalling Chorionic Gonadotropin/Hydroxocobalamin Injectable vials due to potential penicillin cross-contamination.

    Product
    Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,000 UNITS/ 5000 mcg per vial, Rx Only, Manufactured by Park Compounding, Irving, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2494-2015·2015-09-09

    Halyard KimVent Closed Suction System Thumb Valve Recall

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, despite appearing locked.

    Product
    KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DT, T-Piece (Product Code 220569) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2538-2015·2015-09-09

    Panoramic X-ray Model PC-1000 Recalled for Jackscrew Nut Failure

    Panoramic Rental Corp. is recalling 7,885 Panoramic X-ray Model PC-1000 units due to a jackscrew nut part failure that could cause device malfunction and injury.

    Product
    Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the user to take panoramic x-ray images as well as cephalometric x-ray images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2501-2015·2015-09-09

    Halyard Health Recalls NovaPlus Trach Care Closed Suction Systems

    Halyard Health is recalling specific NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.

    Product
    NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece  MDI Adapter, 14F (Product Code 2V220158) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2581-2015·2015-09-09

    Customed Open Heart Trays Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 56 Open Heart Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    OPEN HEART TRAY 1/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2559-2015·2015-09-09

    Customed OB Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation and package integrity.

    Product
    OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2542-2015·2015-09-09

    Wright Medical Recalls CrossCHECK Non-Locking Screws Due to Malfunction Risk

    Wright Medical Technology is recalling 5,687 CrossCHECK Non-Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.

    Product
    CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2564-2015·2015-09-09

    Customed Pery Gyn Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 460 Pery Gyn Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2521-2015·2015-09-09

    Halyard Health Recalls KimVent Closed Suction Systems Due to Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning, despite appearing closed.

    Product
    KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Manifold (Product Code 201) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2015·2015-09-09

    Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 55 plastic surgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2665-2015·2015-09-09

    Customed Tummy Tuck Pack Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2562-2015·2015-09-09

    Customed PERI GYN PACK CS/6 Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 228 PERI GYN PACK CS/6 units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2508-2015·2015-09-09

    Halyard KimVent Closed Suction System Recall for Valve Defect

    Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, even when it appears locked.

    Product
    KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2015·2015-09-09

    Volcano Pioneer Plus Re-Entry Catheter Recalled for Manufacturing Defect

    Volcano Corporation is recalling 5,042 Pioneer Plus Re-Entry Catheters due to a manufacturing defect that may allow a small wire to extend through the catheter shaft.

    Product
    Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus) is intended to facilitate the placement and positioning of catheters…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2656-2015·2015-09-09

    Customed Urethral Catheter Tray Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 5,500 urethral catheter trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    URETHRAL CATHETER TRAY CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2702-2015·2015-09-09

    Customed Incision and Drainage Trays Recalled for Sterilization Defects

    Customed, Inc. is recalling 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2641-2015·2015-09-09

    Customed O.B. Packs Recalled for Sterilization Validation Deficiencies

    Customed, Inc. is recalling 125 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.

    Product
    O.B. PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighCPSC·15237·2015-09-09

    Panasonic Recalls Metal Cutter Saws Due to Laceration Hazard

    Panasonic is recalling specific cordless metal cutter saw kits because the lower blade guard can get stuck, exposing the blade and posing a laceration hazard.

    Product
    Metal Cutter Saw Kit and Metal Cutter Combo Kit
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2664-2015·2015-09-09

    Customed Face Lift Medical Kits Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 24 units of Face Lift medical kits due to inadequate validation of sterilization processes and package integrity.

    Product
    FACE LIFT 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2662-2015·2015-09-09

    Customed Hair Restoration Packs Recalled for Sterilization Validation Issues

    Customed, Inc. is recalling 18 units of Hair Restoration Packs due to inadequate validation of sterilization processes and package integrity.

    Product
    HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
    Category
    Medical Device
    Distribution
    1 state

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