FDAClass IISeptember 9, 2015

MINOR PACK 4/CS Used by medical staff to perform recall

MINOR PACK 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Why was MINOR 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:9002511 Lots: 140412903 exp. 5/31/16 140915507 exp. 10/31/15 141216305 exp. 12/31/15 150116550 exp. 1/31/16 150116549 exp. 1/31/16 150116552 exp. 1/31/16 150116551 exp. 1/31/16 150317840 exp. 4/30/16 150317839 exp. 4/30/16 150317841 exp. 4/30/16 150317841 exp. 4/30/16 150317842 exp. 4/30/16 150317843 exp. 4/30/16 150317844 exp. 4/30/16 150418372 exp. 4/30/16 150418373 exp. 4/30/16 150418374 exp. 4/30/16 150418375 exp. 5/31/16

Product
MINOR 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
1452
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