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

901–1000 of 1186

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-2576-2015·2015-09-09
Customed Premium Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 508 packs of Premium Laparotomy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM LAPAROTOMY PK CUSTOMED 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-2604-2015·2015-09-09
Customed O.B. Packs Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 132 O.B. Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK 4/CS REV. 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-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-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-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-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-2579-2015·2015-09-09
Customed Neuro Spine Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 123 Neuro Spine Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
NEURO SPINE 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-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-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-2566-2015·2015-09-09
Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,960 Foley Catheter Kits II 16FR distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FOLEY CATHETER KIT II 16FR. 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
HighCPSC·15238·2015-09-09
Baja Motorsports Recalls Mini Bikes Due to Front Fork Separation Hazard
Baja Motorsports is recalling about 4,600 gas-powered mini bikes because the front fork can separate from the wheel, posing fall and crash hazards.
Product
Mini bikes
Category
Consumer Product
Distribution
Distributed nationwide
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 (Drugs)·D-1340-2015·2015-09-09
Artesunate Injection Recalled for Potential Penicillin Cross Contamination
South Coast Specialty Compounding is recalling 172 vials of Artesunate Lyophilized Powder for Injection due to potential penicillin cross-contamination.
Product
Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufactured by Park Compounding, Irvine, CA
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2489-2015·2015-09-09
Arrow International Recalls PICC and VPS Access Kits with Touhy Borst Catheters
Arrow International is recalling PICC and VPS Access Kits with Touhy Borst catheters due to saline leakage from unsecured connections. No injuries have been reported.
Product
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2524-2015·2015-09-09
Stryker Neptune 2 Waste Management System Docking Station Recall
Stryker is recalling Neptune 2 Waste Management System Docking Stations because a defective component may cause fluid leaks during use.
Product
Neptune 2 Waste Management System Docking Station (120V and 230V), New and Refurbished Product Usage: The Stryker Docking Station (Docker) is a component of the Neptune 2 Waste Management System. The Stryker Rover, another component of the system, is a mobile unit used to…
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 (Devices)·Z-2694-2015·2015-09-09
Customed Recalls O.R. Towels Due to Sterilization Process Validation Issues
Customed, Inc. is recalling 300 cases of O.R. Towels distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
O.R. TOWELS 25/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-2701-2015·2015-09-09
Customed Recalls Carpal Tunnel Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 588 units of Carpal Tunnel Large Surgical Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
CARPAL TUNEL LARGE 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-2646-2015·2015-09-09
Customed Inc Recalls Sterile Hip and Knee Replacement Surgical Kits
Customed, Inc. is recalling 39 sterile hip and knee replacement kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
HIP AND KNEE REPLACEMENT 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-2613-2015·2015-09-09
Customed HIP Ortho. Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling HIP Ortho. Packs due to inadequate validation of sterilization processes and package integrity. The products were distributed only in Puerto Rico.
Product
HIP ORTHO. 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-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-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…
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-2565-2015·2015-09-09
Customed Tracheotomy Care Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 3,550 Tracheotomy Care Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
TRACHEOTOMY CARE 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
HighFDA (Devices)·Z-2716-2015·2015-09-09
Customed PERI GYN PACK recalled for sterilization validation issues
Customed, Inc. is recalling 115 units of PERI GYN PACK 5/CS due to inadequate validation of sterilization processes and package integrity.
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
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2606-2015·2015-09-09
Customed Minor Laparotomy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 945 Minor Laparotomy Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
MINOR LAP. PACK 5/CS REV. 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-2661-2015·2015-09-09
Customed Obstetrical Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling obstetrical surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OBSTETRICAL SURGICAL 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-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-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-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-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-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-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-2612-2015·2015-09-09
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 546 ophthalmic surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OPHTHALMIC 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-2657-2015·2015-09-09
Customed Laparotomy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 1,866 laparotomy surgical packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROTOMY SURGICAL 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-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…
Category
Medical Device
Distribution
Distributed nationwide
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-2528-2015·2015-09-09
Recall of Mahurkar Elite Acute Dual Lumen Catheter Trays Due to Sterility Concerns
Covidien LLC is recalling 116 Mahurkar Elite Acute Dual Lumen Catheter Trays because sterility may be compromised. The affected devices were distributed nationwide in the US.
Product
Mahurkar Elite Acute Dual Lumen Catheter Tray, High Flow Straight Extensions with IC* Safety Components, 13.5 Fr x 24 cm Item Code: 8888211424 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling…
Category
Medical Device
Distribution
Distributed nationwide
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-2514-2015·2015-09-09
Halyard KimVent Closed Suction System Thumb Valve Recall
Halyard Health is recalling KimVent Turbo-Cleaning 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, 14 F, T-Piece (Product Code 22705); KimVent* Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece (Product Code 2270135) A tracheobronchial suction catheter is a device that is attached to a port of the…
Category
Medical Device
Distribution
Distributed nationwide
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-2555-2015·2015-09-09
Customed Minor Procedure Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 80 Minor Procedure Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
MINOR PROCEDURE PACK 40/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-2681-2015·2015-09-09
Customed Laparoscopy OB 6/CS Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 36 units of Laparoscopy OB 6/CS devices distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY OB 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-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…
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-2497-2015·2015-09-09
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* Closed Suction System for Adults, 12 F, T-Piece,12 in Tracheostomy (Product Code 215135); KimVent* Closed Suction System for Adults, 12 F, T-Piece, 12 in Trach (Product Code 21513511) A tracheobronchial suction catheter is a device that is attached to a port of the…
Category
Medical Device
Distribution
Distributed nationwide
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-2522-2015·2015-09-09
Halyard KimVent Closed Suction Systems 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 the closed system.
Product
KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction…
Category
Medical Device
Distribution
Distributed nationwide
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-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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2586-2015·2015-09-09
Customed Orthopedic Implants Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 orthopedic implants distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
IMPLANTE DE ORTHOPEDIA 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-2658-2015·2015-09-09
Customed Basic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 432 Basic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
BASIC PACK 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-2614-2015·2015-09-09
Customed Ophthalmic Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 360 Ophthalmic Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
OPHTHALMIC 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-2552-2015·2015-09-09
Customed Laparoscopy Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 339 packs of Laparoscopy PK 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
LAPAROSCOPY PK 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-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-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-2622-2015·2015-09-09
Customed Angiography Packs Recalled for Sterilization Process Validation Deficiencies
Customed, Inc. is recalling 1,128 angiography packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY PACK CUSTOMED 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-2708-2015·2015-09-09
Customed Urology Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 155 Urology Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
UROLOGY 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-2507-2015·2015-09-09
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, potentially compromising the closed system.
Product
KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE, MDI (Product 8224); KimVent* Wet Pak* Closed Suction System for Adults, 14 F, DSE (Product Code 22106); KimVent* Closed Suction System for Adults, 14 F, DSE, Wet Pak (Produce Code 221036) A tracheobronchial suction…
Category
Medical Device
Distribution
Distributed nationwide
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 (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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2654-2015·2015-09-09
Customed Shoulder Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 177 units of Shoulder Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER 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-2510-2015·2015-09-09
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 safety.
Product
NovaPlus Trach Care* Closed Suction System for Adults, Double Swivel Elbow, Directional Tip, 14F (Product Code 2V22109) 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…
Category
Medical Device
Distribution
Distributed nationwide
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-2523-2015·2015-09-09
Halyard KimVent Pediatric Closed Suction System Thumb Valve Defect Recall
Halyard Health is recalling KimVent Wet Pak Closed Suction Systems for pediatrics because the thumb valve may remain partially open after use, potentially compromising airway safety.
Product
KimVent* Wet Pak* Closed Suction System for Pediatrics, 10 F, Y Adapter (Product Code 8281) 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-2597-2015·2015-09-09
Customed Retina Pack Recall Due to Sterilization Validation Issues
Customed, Inc. is recalling 21 units of Retina Pack 7/CS distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
RETINA PACK 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 (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 (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-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-2624-2015·2015-09-09
Customed Femoral Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 152 units of Femoral Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
FEMORAL 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-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-2651-2015·2015-09-09
Customed Tummy Tuck and Breast Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 24 Tummy Tuck & Breast Packs distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
TUMMY TUCK & BREAST PACK-RFMHI 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-2685-2015·2015-09-09
Customed Gauze Sponges Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling sterile gauze sponges due to inadequate validation of sterilization processes and package integrity.
Product
GAUZE SPONGE 4"X4" 16 PLY XRD 1280/CS (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
HighFDA (Devices)·Z-2572-2015·2015-09-09
Customed Open Heart Trays Recalled for Sterilization Validation Defects
Customed, Inc. is recalling 106 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-2713-2015·2015-09-09
Customed recalls cataract packs due to sterilization validation issues
Customed, Inc. is recalling cataract packs distributed in Puerto Rico because the company could not adequately validate the sterilization processes and package integrity for these sterile products.
Product
CATARACT PACK 6/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-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-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-2590-2015·2015-09-09
Customed Laparotomy Kits Recalled for Sterilization Process Validation Issues
Customed, Inc. is recalling 1,072 units of Laparotomy Kits due to inadequate validation of sterilization processes and package integrity.
Product
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-2679-2015·2015-09-09
Customed Minor Laparotomy Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 675 Minor Laparotomy Kits distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
MINOR LAPAROTOMY 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-2683-2015·2015-09-09
Customed Polyreinforced Surgical Gowns Recalled for Sterilization Validation Issues
Customed, Inc. is recalling polyreinforced surgical gowns due to inadequate validation of sterilization processes and package integrity.
Product
GOWN POLYREINF XLGE TOWEL/W 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-2598-2015·2015-09-09
Customed Femoral Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 320 units of Femoral Packs due to inadequate validation of sterilization processes and package integrity.
Product
FEMORAL 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-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-2691-2015·2015-09-09
Customed Angiography Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 370 units of Angiography Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ANGIOGRAPHY 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-2603-2015·2015-09-09
Customed Recalls Peri Gyn Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 80 units of Peri Gyn Packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
PERI GYN 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-2652-2015·2015-09-09
Customed Shoulder Arthroscopy Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 10 units of Shoulder Arthroscopy Packs in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
SHOULDER ARTHROSCOPY 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-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-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-2520-2015·2015-09-09
Halyard Recalls KimVent Closed Suction Systems Due to Valve Malfunction
Halyard Health is recalling KimVent Closed Suction Systems for neonates and pediatrics because the thumb valve may remain partially open after suctioning.
Product
KimVent* Closed Suction System for Neonates/Pediatrics, 5 F, Y-Adapter (Product Code 195); KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Y-Adapter (Product Code 196); KimVent* Closed Suction System for Neonates/Pediatrics, 7 F, Y-Adapter (Product Code 197)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2503-2015·2015-09-09
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, 12 F, Elbow (Product Code 216); KimVent* Closed Suction KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 221); KimVent* Closed Suction System for Adults, 14 F, Elbow (Product Code 22113) A tracheobronchial suction…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2699-2015·2015-09-09
Customed Arthroscopy Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 536 Arthroscopy Surgical Packs 4/C distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY SURGICAL PACK 4/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-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-2698-2015·2015-09-09
Customed Cesarean Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 525 units of Cesarean Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
CESAREAN 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-2714-2015·2015-09-09
Customed Arthroscopy PK L/F 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 115 units of Arthroscopy PK L/F 5/CS due to inadequate validation of sterilization processes and package integrity.
Product
ARTHROSCOPY PK L/F 5/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-2518-2015·2015-09-09
Halyard Health 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 suctioning, potentially compromising the closed system.
Product
KimVent* Multi-Access Port Closed Suction System for Adults,Tracheostomy, DSY, MDI, 14 F (Product Code 240438-5) 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…
Category
Medical Device
Distribution
Distributed nationwide
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…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2580-2015·2015-09-09
Customed Recalls Pediatric Lap Packs Due to Sterilization Validation Issues
Customed, Inc. is recalling 48 Pediatric Lap Packs distributed in Puerto Rico because the sterilization processes and package integrity were not adequately validated.
Product
PEDIATRIC LAP PACK 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
ModerateFDA (Food)·F-3077-2015·2015-09-09
Big Train Vanilla Chai Tea Mix Recalled for Mislabeling Sugar Content
Big Train Inc. is recalling one lot of Vanilla Chai Tea Latte mix because it is labeled 'No Sugar Added' but actually contains sugar.
Product
Big Train Chai Tea Vanilla Chai, Naturally and Artificially Flavored Drink Mix, No Sugar Added, NET WT 56 oz (3 LB 8 OZ) 1.59kg lb), UPC 6 42628 10359 8. Case UPC code: 10642628103526 Soft sided 3.5 lb. pouch style package. Each case has 4 pouches.
Category
Food
Distribution
6 states

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