FDAFDA · Food and drugs·Recall number Z-1490-2016
Catalog Number: 900921A C-SECTION 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: SL15175 (150619191) 30-JUN-16 SL15177 (150619191) 30-JUN-16 SL15197 (150719813) 31-JUL-16 SL15199 (150719813) 31-JUL-16 SL15222 (150820354) 31-AUG-16 SL15222 (150820353) 31-AUG-16 SL15224 (150820353) 31-AUG-16 SL15225 (150820354) 31-AUG-16 SL15261 (150920717) 30-SEP-16 SL15261 (150920716) 30-SEP-16 SL15264 (150920716) 30-SEP-16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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