Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 35 of 63
Customed, Inc
Class II Terminated
Catalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1405-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1442-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002609 ARTHOSCOPY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1452-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001062 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1409-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1402-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900921A C-SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1490-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900410 CESAREAN SECTION SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1468-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1478-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1443-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900540 WOUND MANAGEMENT TRAY III Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1476-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900982 ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1493-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1483-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001061 PERI-GYN SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1408-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900576A LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds,...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1479-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1407-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1446-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900486 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1473-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1431-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900281A LAPAROTOMY PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1460-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1397-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900474 LAPAROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1471-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001538 DRESSING CHANGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1429-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002224 SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1445-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900741A 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.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1485-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1415-2016 April 20, 2016 Fajardo, PR