FDAFDA · Food and drugs·Recall number Z-1438-2016
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.
Published April 20, 2016 · Recall initiated: January 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Customed, Inc
- Distributor
- Distributed only in Puerto Rico.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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