September 2015 recalls

1,186 recalls were announced in September 2015.

What the numbers show

Critical: 119
Severe: 561
High: 378
Moderate: 103
Low: 25

Of the 1,186 recalls this month scored against our rubric, 10% are Critical, 47% are Severe.

Which agencies issued them

901–1000 of 1186

HighFDA (Devices)·Z-2531-2015·2015-09-09
Mahurkar Elite Acute Dual Lumen Catheter Tray Recalled for Sterility Concerns
The FDA is recalling 67 kits of Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The product was distributed nationwide.
Product
Mahurkar Elite Acute Dual Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12 Fr x 16 cm Item Code: 8888222416 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2672-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 507 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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
HighFDA (Devices)·Z-2506-2015·2015-09-09
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, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 2210); KimVent* Closed Suction System for Adults, 12 F, DSE (Product 21603); KimVent* Closed Suction System for Adults, 14 F, DSE (Product Code 22103); KimVent* Closed Suction System for Adults, 14 F, DSE (Product
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2638-2015·2015-09-09
Customed Minor Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 1,452 units of Minor Packs due to inadequate validation of sterilization processes and package integrity.
Product
MINOR PACK 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-2492-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of t
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2601-2015·2015-09-09
Customed Labor and Delivery Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 344 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LABOR & DELIVERY 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-2618-2015·2015-09-09
Customed Angiography Kits Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 388 angiography kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY 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
HighFDA (Devices)·Z-2677-2015·2015-09-09
Customed Labor and Delivery Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 300 Labor and Delivery kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LABOR & DELIVERY 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-2602-2015·2015-09-09
Customed Open Heart Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Open Heart Trays due to inadequate validation of sterilization processes and package integrity.
Product
OPEN HEART TRAY CUSTOMED 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-2635-2015·2015-09-09
Customed sterile medical products recalled due to sterilization validation issues
Customed, Inc. is recalling sterile medical products used for surgical and patient care procedures in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
(1) (2) 10/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
HighFDA (Devices)·Z-2666-2015·2015-09-09
Customed Face Packs Recalled Due to Sterilization Validation Issues
Customed, Inc. is recalling 16 units of Face Packs in Puerto Rico because the sterilization process and package integrity were not adequately validated.
Product
FACE PACK FJG 8/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-2717-2015·2015-09-09
Customed C-Section Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 92 C-Section Kits due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
C-SECTION PK 2/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
HighFDA (Devices)·Z-2631-2015·2015-09-09
Customed Central Line Full Body Drapes Recalled for Sterilization Issues
Customed, Inc. is recalling 56 units of Central Line Full Body Drapes due to inadequate validation of sterilization processes and package integrity.
Product
CENTRAL LINE FULL BODY DRAPE CUSTOMED 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
HighFDA (Devices)·Z-2584-2015·2015-09-09
Customed Wound Management Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 580 wound management kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAGEMENT CUSTOMED 20/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-2595-2015·2015-09-09
Customed Recalls Surgical Gowns Due to Sterilization Validation Issues
Customed, Inc. is recalling 180 surgical gowns distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
Gown, surgical 30/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-2568-2015·2015-09-09
Customed Neuro Pack 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 15 packs of NEURO PACK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
NEURO 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
HighFDA (Devices)·Z-2680-2015·2015-09-09
Customed Laparoscopy Kits Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 244 laparoscopy kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
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
HighFDA (Devices)·Z-2682-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 78 units of Laparoscopy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PACK 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-2554-2015·2015-09-09
Customed Major Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,084 packs of Major Laparotomy Packs due to inadequate validation of sterilization processes and package integrity.
Product
MAJOR LAPAROTOMY 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
HighFDA (Devices)·Z-2706-2015·2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 264 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY 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-2600-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 96 units of Cesarean Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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
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-2709-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Arthroscopy Packs due to inadequate validation of sterilization processes and package integrity for products released as sterile.
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
HighFDA (Food)·F-3074-2015·2015-09-09
Kilwin's Recalls Sugar Free Milk Chocolate Caramels Due to Undeclared Cashew
Kilwin's is recalling 5-ounce containers of Sugar Free Milk Chocolate Caramels because they may contain undeclared cashew, posing a risk to those with allergies.
Product
5 ounce containers of SUGAR FREE Milk Chocolate Caramels. The 5 oz container is a cardboard box with clear plastic window on the front. Retail packages are packed 4 per shipping case.
Category
Food
Distribution
12 states
HighFDA (Devices)·Z-2696-2015·2015-09-09
Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 130 units of Peri Gyn Packs in Puerto Rico because sterilization processes and package integrity were not adequately validated.
Product
PERI GYN 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-2481-2015·2015-09-09
Beckman Coulter Recalls Isoton 4 Diluent for Hematology Systems
Beckman Coulter is recalling specific lots of Isoton 4 Diluent because they may compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
Product
COULTER ISOTON 4 Diluent, Catalog No. 8547148. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2569-2015·2015-09-09
Customed Wound Management Trays Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,248 wound management trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND MANAG.TRAY 24/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-2732-2015·2015-09-09
C.R. Bard Recalls Magic3 Intermittent Catheters Due to Sterile Barrier Breach
C.R. Bard is recalling 8,970 Magic3 Intermittent Catheters because the sterile barrier packaging may be breached, potentially compromising sterility.
Product
Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-2634-2015·2015-09-09
Customed Extremity Arm Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 148 Extremity Arm Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EXTREMITY ARM PACK 4/CS HOSP. DR. CENTER 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-2490-2015·2015-09-09
Trilliant Surgical Recalls Out-of-Specification Fibula Plates
Trilliant Surgical Ltd. is recalling 28 units of VL Gridlock Fibula Plates because insufficient thread depth may limit locking screw functionality.
Product
7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive pr
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2479-2015·2015-09-09
Siemens RAPIDPoint 500 Blood Gas Analyzer Recalled for Data Integrity Issues
Siemens is recalling RAPIDPoint 500 Blood Gas Analyzers because simultaneous use of Serial and Ethernet ports may cause data duplication, loss, or patient mismatch.
Product
RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 10697306 This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2493-2015·2015-09-09
Halyard KimVent Closed Suction System Recalled Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising airway protection.
Product
KimVent* Closed Suction System for Adults, 14 F, T-Piece, MDI (Product Code 8308) 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-2639-2015·2015-09-09
Customed Shoulder Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 12 units of Shoulder Packs (I) (2) due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER PACK (I) (2) 6/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
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 (Food)·F-3066-2015·2015-09-09
Willit House Dark Chocolate Bars Recalled for Undeclared Soy Lecithin
Willit House Chocolate Co is recalling Dark Chocolate with Cranberry, Roasted Nuts & Sea Salt bars because they contain undeclared soy lecithin.
Product
Dark Chocolate with Cranberry, Roasted Nuts & Sea Salt, sold under brand Willit House. Each bar is wrapped in gold foil and then wrapped with a box. Each box contains 12 bars and each bar has a net weight 60 gram.
Category
Food
Distribution
1 state
HighFDA (Food)·F-3083-2015·2015-09-09
Westbrook's Horseradish Dilly Beans Recalled for Potential Underprocessing
Westbrook's Cannery is recalling 12-ounce jars of Horseradish Dilly Beans because they may be underprocessed. Consumers should stop using the product.
Product
Westbrook's Horseradish Dilly Beans, Net WT. 12 oz (354.882G) glass jars, Ingredients: Green Beans, White Distilled Vinegar, Water, Pickling Salt, Horseradish, Garlic Cloves, Dill Seed, Dill Weed, Alum www.wesbrookscannery.com 330-874-8120 UPC 8 53238 00441 4
Category
Food
Distribution
11 states
HighFDA (Food)·F-3080-2015·2015-09-09
Westbrook's Cannery Recalls Dill Pickles Due to Underprocessing Concerns
Westbrook's Cannery is recalling 16 oz glass jars of Dill Pickles because the products may be underprocessed. Consumers should check lot codes and stop using the product.
Product
WESTBROOK'S CANNERY DILL PICKLES, 16 oz (453.592g) glass jars, Ingredients: White Distilled Vinegar, Water, Cucumbers, Alum, Pickling Salt, Spices 206 Dueber Ave SW Canton, OH 44706 234-214-8215 www.wesbrookscannery.com UPC 8 53238 00406 3
Category
Food
Distribution
11 states
HighFDA (Devices)·Z-2670-2015·2015-09-09
Customed Basic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 77 units of Basic Packs Without Gown due to inadequate validation of sterilization processes and package integrity.
Product
BASIC PACK W/OUT GOWN 11/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-2686-2015·2015-09-09
Customed Laparotomy Basic Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of Laparotomy Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY BASIC PACK 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-2649-2015·2015-09-09
Customed Open Heart Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 27 Open Heart Packs due to inadequate validation of sterilization processes and package integrity.
Product
OPEN HEART PACK 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-2496-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after suctioning, compromising the closed system.
Product
KimVent* Closed Suction System for Adults, 14 F, D-Tip, T-Piece (Product Code 22059); KimVent* Closed Suction System for Adults, 14 F, T-Piece, Directional Tip (Product Code 8155) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2593-2015·2015-09-09
Customed Dressing Change Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,050 units of Dressing Change kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
DRESSING CHANGE 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-2637-2015·2015-09-09
Customed Urology Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 450 Urology Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY SURGICAL PACK 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-2505-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Defect
Halyard Health is recalling KimVent Closed Suction Systems because the thumb valve may remain partially open after use, potentially compromising the closed system.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 2276); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, Elbow (Product Code 22169) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as n
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2623-2015·2015-09-09
Customed Knee Arthroscopy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 188 Knee Arthroscopy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
KNEE ARTHROSCOPY 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
HighFDA (Devices)·Z-2715-2015·2015-09-09
Customed Laparotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 243 units of Laparotomy Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK 3/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
HighFDA (Devices)·Z-2659-2015·2015-09-09
Customed Orthopedic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 90 units of Orthopedic Pack Basic surgical packs distributed in Puerto Rico due to inadequate sterilization process validation and package integrity concerns.
Product
ORTHOPEDIC PACK BASIC 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-2587-2015·2015-09-09
Customed E.N.T. PK 7/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 63 units of E.N.T. PK 7/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
E.N.T. PK 7/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-2511-2015·2015-09-09
Halyard NovaPlus Trach Care Closed Suction System Thumb Valve Recall
Halyard Health is recalling NovaPlus Trach Care Closed Suction Systems because the thumb valve may remain partially open after suctioning, potentially compromising the closed system.
Product
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, 14F (Product Code 2V2210) 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 airwa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2596-2015·2015-09-09
Customed Universal Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Universal Packs used for surgical procedures due to inadequate validation of sterilization processes and package integrity.
Product
UNIVERSAL 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
HighFDA (Devices)·Z-2628-2015·2015-09-09
Customed Ear Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 48 units of Ear Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EAR 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
HighFDA (Devices)·Z-2650-2015·2015-09-09
Customed Face Pack Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 24 units of Face Pack MRT due to inadequate validation of sterilization processes and package integrity.
Product
FACE PACK MRT 8/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
HighFDA (Devices)·Z-2607-2015·2015-09-09
Customed Urology PK 5/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 10 units of UROLOGY PK 5/CS kits in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PK 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-2693-2015·2015-09-09
Customed Arthroscopy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 320 Arthroscopy PK 5/CS kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK 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-2549-2015·2015-09-09
Customed Suture Removal Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 20,200 Suture Removal Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SUTURE REMOVAL KIT CUSTOMED 100/CS Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2611-2015·2015-09-09
Customed Mayo Stand Covers Recalled for Sterilization Process Defects
Customed, Inc. is recalling 540 units of Mayo Stand Covers due to inadequate validation of sterilization processes and package integrity.
Product
MAYO STAND COVER W/CSR WRAP 30/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-2575-2015·2015-09-09
Customed Premium Cesarean Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 25 Premium Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM CESAREAN PACK CUSTOMED 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-2541-2015·2015-09-09
Wright Medical CrossCHECK Locking Screw Recall for Intraoperative Malfunction Risk
Wright Medical Technology is recalling 107 CrossCHECK Locking Screws because they may pass through the plate if excessive torque is applied, potentially causing intraoperative malfunction.
Product
CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2689-2015·2015-09-09
Customed Utility Drapes Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Utility Drapes due to inadequate validation of sterilization processes and package integrity.
Product
UTILITY DRAPE END PRODUCT 50PK/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-2625-2015·2015-09-09
Customed Lithotomy Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 370 units of Lithotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LITHOTOMY PACK 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 (Drugs)·D-1413-2015·2015-09-09
Estradiol Cream Recalled for Potential Penicillin Cross Contamination
South Coast Specialty Compounding is recalling 24 prescriptions of Estradiol cream due to potential penicillin cross contamination.
Product
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Category
Drug
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 within
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2621-2015·2015-09-09
Customed Gauze Recalled Due to Sterilization Validation Deficiencies
Customed, Inc. is recalling 2-inch by 2-inch gauze pads because of inadequate validation of sterilization processes and package integrity.
Product
GAUZE 2" X 2" PRODUCTION ONLY 1500PK/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
HighFDA (Devices)·Z-2719-2015·2015-09-09
Siemens Syngo.plaza PACS Recalled for Potential Data Loss and Mix-ups
Siemens Medical Solutions is recalling 37 Syngo.plaza PACS units due to a potential issue that could lead to data loss and patient data mix-ups.
Product
Syngo.plaza; picture archiving and communications system Product Usage: Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2645-2015·2015-09-09
Customed Arthroscopy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 75 units of 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
HighFDA (Devices)·Z-2504-2015·2015-09-09
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, even when it appears locked.
Product
KimVent* Closed Suction System for Adults, 14 F, Elbow, D-Tip (Product Code 2219) 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-2599-2015·2015-09-09
Customed Laparoscopic Cholecystectomy Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 120 units of laparoscopic cholecystectomy kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
LAPAROS.CHOLE 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
HighFDA (Devices)·Z-2548-2015·2015-09-09
Customed Angiodrape PK 4/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 192 packs of Angiodrape PK 4/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIODRAPE 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
HighFDA (Devices)·Z-2640-2015·2015-09-09
Customed Laparotomy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 304 laparotomy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY PACK 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 (Drugs)·D-1412-2015·2015-09-09
Bi-Est Testosterone Cream Recalled for Penicillin Cross Contamination
South Coast Specialty Compounding is recalling Bi-Est Testosterone cream due to potential penicillin cross-contamination. The affected products were distributed nationwide.
Product
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2700-2015·2015-09-09
Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 639 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ORTHO-IMPLANT 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
HighFDA (Devices)·Z-2500-2015·2015-09-09
Halyard Recalls NovaPlus Trach Care Closed Suction Systems Due to Valve Defect
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, T-Piece, 14F (Product Code 2V220135); NovaPlus Trach Care* Closed Suction System for Adults, Clear T-Piece, 14F (Product Code 2V2205) A tracheobronchial suction catheter is a device that is attached to a port of the airway c
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2605-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 104 units of Cesarean Packs 4/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN PACK 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-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-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; 3.0
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2629-2015·2015-09-09
Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
NEURO PACK 2/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-2556-2015·2015-09-09
Customed Wound Closure Tray Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,050 Wound Closure Tray I units distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
WOUND CLOSURE TRAY I 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-2592-2015·2015-09-09
Customed Urology Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 352 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY PACK 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-2616-2015·2015-09-09
Customed Recalls Sterile Surgical Kits Due to Sterilization Validation Issues
Customed, Inc. is recalling 248 units of sterile surgical kits in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
HIGADO Y PANCREA 2/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-2632-2015·2015-09-09
Customed Lumbar Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 12 Lumbar Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LUMBAR PACK 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-2704-2015·2015-09-09
Customed General Minor PK 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 425 units of General Minor PK 5/CS surgical kits due to inadequate validation of sterilization processes and package integrity.
Product
GENERAL MINOR PK 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-2571-2015·2015-09-09
Customed Laparoscopic OB GYN Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 95 packs of laparoscopic OB GYN kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSC. OB GYN PK 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-2669-2015·2015-09-09
Customed Breast Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 33 units of Breast Pack-TPSC in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
BREAST PACK-TPSC 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
HighFDA (Devices)·Z-2630-2015·2015-09-09
Customed Laparoscopy-Colorectal Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 354 units of Laparoscopy-Colorectal Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/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-2498-2015·2015-09-09
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, potentially compromising the closed system.
Product
KimVent* Turbo-Cleaning Closed Suction System for Adults, 10 F, T-Piece (Product Code 227105) 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-2509-2015·2015-09-09
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 closed.
Product
KimVent* Closed Suction System for Adults, 14 F, DSE, DT (Product Code 22109) 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-2647-2015·2015-09-09
Customed Extremity Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 285 units of Extremity Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
EXTREMITY PACK 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-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-2583-2015·2015-09-09
Customed Umbilical Vessel Catheter Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 48 umbilical vessel catheter kits due to inadequate validation of sterilization processes and package integrity.
Product
UMBILICAL VESSEL CATHETER KIT CUSTOMED 8/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-2653-2015·2015-09-09
Customed Medical Device Recall for Sterilization Validation Deficiencies
Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
REEMPLAZO DE RODILLA Y CADERA 2/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-2712-2015·2015-09-09
Customed C-Section Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 874 C-Section Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
C-SECTION SURGICAL PACK 2/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
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
HighFDA (Devices)·Z-2574-2015·2015-09-09
Customed Laminectomy Pack Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling Laminectomy Pack 3/C units in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAMINECTOMY PACK 3/C 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-2480-2015·2015-09-09
Beckman Coulter Recalls LH Series Diluent Due to Cuvette Compromise Risk
Beckman Coulter is recalling LH Series Diluent because it may eventually compromise the Hgb cuvette in LH 750 and LH780 Hematology Systems.
Product
COULTER LH Series Diluent, Catalog No. 8547194, Product Labeling A40192-AD. The diluent provides the ability to analyze portions of the diluted blood sample for different blood cell types, such as red blood cells and platelets.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2570-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 138 laparoscopy packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PACK 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-2703-2015·2015-09-09
Customed Skin Staple Remover Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 2,180 Skin Staple Remover Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SKIN STAPLE REMOVER KIT 80/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-2550-2015·2015-09-09
Customed O.B. PK Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 48 packs of O.B. PK surgical packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. 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
HighFDA (Devices)·Z-2513-2015·2015-09-09
Halyard KimVent Closed Suction Systems Recalled Due to 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 Systems for Adults, 14 F, Qwik Clip (Product Code 2273) 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
ModerateFDA (Food)·F-3069-2015·2015-09-09
HoneyCombs Formula IM Recalled for Excessive Coliform Bacteria
HoneyCombs Industries is recalling 55 bottles of Formula IM because the powdered golden seal ingredient contained coliform bacteria levels above the specified limit.
Product
Formula IM packaged in 1 FL OZ (29mL) droppers. HoneyCombs Industries, 10671 6075 Road, Montrose, CO 81403.
Category
Food
Distribution
Distributed nationwide

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