UROLOGY PACK 4/CS Used by medical staff to perform recall
UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Why was UROLOGY PACK 4/CS Used by medical staff to perform 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:9001521 Lots: 141015699 exp. 11/30/15 141115980 exp. 12/31/15 150116560 exp. 2/28/16 150116560 exp. 2/28/16 150217271 exp. 2/28/16 150317613 exp. 4/30/16 150317616 exp. 4/30/16 150317615 exp. 4/30/16 150518646 exp. 5/31/16 150418301 exp. 5/31/16 150518647 exp. 5/31/16 150418302 exp. 5/31/16 150619387 exp. 6/30/16
- Product
- UROLOGY PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
- Recalling firm
- Customed, Inc
- Quantity
- 352
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)