PERY-GYN SURGICAL PACK 6/CS Used by medical staff to recall
PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Why was PERY-GYN SURGICAL PACK 6/CS Used by medical staff to recalled?
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Code:900548A Lots: 141015718 exp. 11/30/15 141216350 exp. 12/31/15 150116506 exp. 12/31/15 150116945 exp. 1/31/16 150116946 exp. 2/28/16 150318003 exp. 3/31/16 150318001 exp. 3/31/16 150318002 exp. 3/31/16 150418416 exp. 4/30/16 150418417 exp. 4/30/16 150518829 exp. 5/31/16 150518829 exp. 5/31/16 150619185 exp. 6/30/16 150619404 exp. 6/30/16
- Product
- PERY-GYN SURGICAL PACK 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 912
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)