Catalog Number: 900345 BASIC SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
This recall has been terminated (originally issued April 14, 2016).
- Recall Initiated
- January 7, 2016
- Posted
- April 14, 2016
- Terminated
- May 3, 2017
- Recall Number
- Z-1466-2016
- Quantity
- 55
- Firm Location
- Fajardo, PR
- Official Source
- View on FDA website ↗
Reason for Recall
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Distribution
Distributed only in Puerto Rico.
Lot / Code Info
LOTS: SL15203 (150719872) 31-JUL-16 SL15225 (150820317) 31-AUG-16 SL15274 (150920821) 30-SEP-16
Root Cause
Packaging
Action Taken
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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