Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 36 of 63
Customed, Inc
Class II Terminated
Catalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, et...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1441-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001300 NEURO-SPINE 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-1421-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900277 SUCTION CATHETER TRAY 14FR WITH SODIUM CHLORIDE 0.9% IRRIGATION Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, sutur...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1458-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900946 STRABISMUS 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-1492-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001091 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-1410-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001521 UROLOGY 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-1428-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900740A 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-1484-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900168 LABOR & DELIVERY 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-1432-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001738 UROLOGY 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-1434-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900403 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-1467-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001294 PREMIUM CESAREAN 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-1417-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001298 PREMIUM ARTHROSCOPY 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-1420-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900944 CATARACT 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-1491-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900036 LAPAROTOMY 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-1403-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001574 LEGGINS 30X42 W/7" CUFF 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-1430-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001202 LAMINECTOMY PK 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-1416-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001297 PREMIUM OBSTETRICAL 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-1419-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001780 OPHTHALMIC 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-1438-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9002829 BASIC SURG 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-1461-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001482 ENT 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-1426-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900774 INCISION AND 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-1487-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001456 WOUND MANAGEMENT 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-1424-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001139 FOLEY CATHETER TRAY 18 FR -5CC-2WAY SILICONE COATED FOLEY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture remo...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-1413-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 9001402 PLASTIC SURGERY 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-1422-2016 April 20, 2016 Fajardo, PR
Customed, Inc
Class II Terminated
Catalog Number: 900345 BASIC 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-1466-2016 April 20, 2016 Fajardo, PR