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Recall Observatory FDA recall evidence

Device product

Catalog Number: 900796 FEMORAL ANGIOGRAPHY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

Z-1489-2016

January 07, 2016

Class II

Product summary

Firm
Customed, Inc
Event
Event 72992
Status
Terminated
Classification
Class II
Quantity
16
Official record key
device-enforcement:Z-1489-2016

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: SL15173 (150418424) 30-JUN-16 SL15175 (150619376) 30-JUN-16 SL15176 (150619376) 30-JUN-16 SL15202 (150619296) 31-JUL-16 SL15202 (150619470) 31-JUL-16 SL15203 (150719296) 31-JUL-16 SL15208 (150719812) 31-JUL-16 SL15211 (150719812) 31-JUL-16 SL15216 (150719812) 31-JUL-16 SL15266 (150920349) 30-SEP-16 SL15267 (150920350) 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