C-SECTION SURGICAL PACK 2/CS Used by medical staff to recall
C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Why was C-SECTION SURGICAL PACK 2/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: 900921A Lots: 141015499 exp. 3/31/16 141216451 exp. 1/31/16 141216364 exp. 12/31/15 150317861 exp. 3/31/16 150317860 exp. 3/31/16 150418472 exp. 4/30/16 150418473 exp. 4/30/16 150518583 exp. 5/31/16 150518584 exp. 5/31/16 150518913 exp. 5/31/16 150619191 exp. 6/30/16
- Product
- C-SECTION SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 874
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)