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Recall Observatory FDA recall evidence

Device product

Catalog Number: 900176 LAPAROTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-1435-2016

January 07, 2016

Class II

Product summary

Firm
Customed, Inc
Event
Event 72992
Status
Terminated
Classification
Class II
Quantity
938
Official record key
device-enforcement:Z-1435-2016

Official wording

Reason: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Code information: LOTS: SL15170 (150619367) 30-JUN-16 SL15170 (150619366) 30-JUN-16 SL15170 (150619364) 30-JUN-16 SL15170 (150619365) 30-JUN-16 SL15187 (150719668) 31-JUL-16 SL15191-01 (150719669) 31-JUL-16 SL15191-01 (150719670) 31-JUL-16 SL15191-01 (150719667) 31-JUL-16 SL15211 (150720120) 31-JUL-16 SL15211 (150720142) 31-JUL-16 SL15211 (150720122) 31-JUL-16 SL15212 (150720143) 31-JUL-16 SL15212 (150720142) 31-JUL-16 SL15212 (150720121) 31-JUL-16 SL15215 (150720122) 31-JUL-16 SL15215 (150720141) 31-JUL-16 SL15215 (150720121) 31-JUL-16 SL15222 (150720120) 31-JUL-16 SL15233 (150820566) 31-AUG-16 SL15233 (150820568) 31-AUG-16 SL15240 (150820569) 31-AUG-16 SL15243 (150820567) 31-AUG-16 SL15243 (150820566) 31-AUG-16 SL15245 (150820698) 31-AUG-16 SL15245 (150820697) 31-AUG-16 SL15245 (150820696) 31-AUG-16

Distribution pattern: Distributed only in Puerto Rico.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    inadequate validation/qualification of sterilization processes
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    inadequate validation/qualification of sterilization