FDAClass IISeptember 9, 2015

PERY GYN PACK CUSTOMED 10/CS Used by medical staff to recall

PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…

Why was PERY GYN PACK CUSTOMED 10/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:9001091 Lots: 141015789 exp. 5/31/19 141115972 exp. 12/31/15 150116985 exp. 1/31/16 150217441 exp. 2/28/16 150217442 exp. 2/28/16 150418281 exp. 4/30/16 150518223 exp. 5/31/16 150519018 exp. 5/31/16

Product
PERY GYN PACK CUSTOMED 10/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
460 packs
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