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Recall Observatory FDA recall evidence

Device product

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.

Z-1438-2016

January 07, 2016

Class II

Product summary

Firm
Customed, Inc
Event
Event 72992
Status
Terminated
Classification
Class II
Quantity
168
Official record key
device-enforcement:Z-1438-2016

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 (150518594) 30-JUN-16 SL15170 (150518592) 30-JUN-16 SL15199 (150719720) 30-JUN-16 SL15199 (150719719) 30-JUN-16 SL15203 (150719720) 30-JUN-16 SL15230 (150819721) 30-JUN-16 SL15231 (150819722) 30-JUN-16 SL15231 (150820230) 30-JUN-16 SL15243 (150820231) 30-JUN-16 SL15243 (150820229) 30-JUN-16 SL15259 (150920791) 30-JUN-16 SL15259 (150920917) 30-JUN-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