LAPAROTOMY PACK 3/CS Used by medical staff to perform recall
LAPAROTOMY PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate
Why was LAPAROTOMY PACK 3/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: 900996 Lots: 141015747 exp. 11/30/15 150116833 exp. 2/28/16 150317665 exp. 3/31/16 150318129 exp. 3/31/16 150518851 exp. 5/31/16
- Product
- LAPAROTOMY PACK 3/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
- 243
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)