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Recall Observatory FDA recall evidence

Device product

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.

Z-1484-2016

January 07, 2016

Class II

Product summary

Firm
Customed, Inc
Event
Event 72992
Status
Terminated
Classification
Class II
Quantity
108
Official record key
device-enforcement:Z-1484-2016

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: SL15169 (150619188) 30-JUN-16 SL15174 (150619405) 30-JUN-16 SL15202 (150719809) 31-JUL-16 SL15208 (150719809) 31-JUL-16 SL15210 (150720043) 31-JUL-16 SL15222 (150720043) 31-JUL-16 SL15233 (150720042) 31-JUL-16 SL15251 (150720042) 31-JUL-16 SL15260 (150920709) 30-SEP-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