FDAClass IISeptember 9, 2015

MINOR LAP. PACK 5/CS REV. Used by medical staff to recall

MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Why was MINOR LAP. PACK 5/CS REV. 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:9001735 Lots: 140814973 exp. 11/30/15 141015733 exp. 10/31/15 141216417 exp. 12/31/15 141216417 exp. 12/31/15 150217361 exp. 2/28/16 150217362 exp. 2/28/16 150217363 exp. 2/28/16 150217364 exp. 2/28/16 150418267 exp. 4/30/16 150418266 exp. 4/30/16 150518660 exp. 5/16/16 150518661 exp. 5/31/16

Product
MINOR LAP. PACK 5/CS REV. Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
945
Distribution
Distributed Only in Puerto Rico.
Recall date
September 9, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls