FDAClass IISeptember 9, 2015

DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to recall

DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…

Why was DRESSING CHANGE CUSTOMED 50/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:9001538 Lots: 141216411 exp. 12/31/15 150116984 exp. 1/31/16 150217358 exp. 2/28/16 150317618 exp. 3/31/16 150418304 exp. 5/31/16 150519012 exp. 3/30/16 150619169 exp. 5/31/16

Product
DRESSING CHANGE CUSTOMED 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture…
Recalling firm
Customed, Inc
Quantity
1050
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