Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

1,565 results found for sterilization Page 42 of 63
Customed, Inc
Class II Terminated
PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS 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-2578-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2624-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
GAUZE SPONGE 2"X2" 8PLY COTTON 1500PK/CS 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-2620-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2708-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2693-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2712-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2709-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2703-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2677-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2659-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
LAPAROSCOPY CHOLE 4/CS 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-2675-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
GAUZE SPONGES 2"x2" 4 PLY ST 2/PK 1500PK/CS 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-2619-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2637-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
PERI GYN PACK CS/6 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2562-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2595-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
SHOULDER 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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2626-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2658-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2679-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2656-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2582-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
FOLEY CATHETER KIT II 18 FR 20/CS 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-2567-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2623-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
C-SECTION PK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2717-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
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. .
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2686-2015 September 9, 2015 Fajardo, PR
Customed, Inc
Class II Terminated
CYSTO TUR PACK CUSTOMED 10/CS REV. C 10/13 NON STERILE Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. ...
Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Z-2558-2015 September 9, 2015 Fajardo, PR