LAPAROSC CHOLE 3/CS Used by medical staff to perform recall
LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…
Why was LAPAROSC CHOLE 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:9001059 Lots: 141015710 exp. 10/31/15 141216433 exp. 12/31/15 150116968 exp. 2/28/16 150116970 exp. 2/28/16 150116969 exp. 2/28/16 150116971 exp. 2/28/16 150116972 exp. 2/28/16 150418276 exp. 4/30/16 150418277 exp. 4/30/16 150418278 exp. 5/31/16 150619301 exp. 6/30/16 150619301 exp. 6/30/16 150619302 exp. 6/30/17 150619302 exp. 6/30/17
- Product
- LAPAROSC CHOLE 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
- 426 kits
- Distribution
- Distributed Only in Puerto Rico.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)