FDAClass IISeptember 9, 2015

SURGICAL PACK 20/CS Used by medical staff to perform recall

SURGICAL PACK 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Why was SURGICAL PACK 20/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:9002224 Lots: 141015709 exp. 2/28/16 141216301 exp. 12/31/15 150116523 exp. 1/31/16 150116524 exp. 1/31/16 150116525 exp. 1/31/16 150116526 exp. 1/31/16 150317725 exp. 4/30/16 150317726 exp. 4/30/16 150418352 exp. 4/30/16 150418351 exp. 4/30/16 150518686 exp. 5/31/16 150518687 exp. 5/31/16 150519027 exp. 6/30/16

Product
SURGICAL PACK 20/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
540
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