FDAClass IISeptember 9, 2015

LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by recall

LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…

Why was LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by 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:9002259A Lots: 141015712 exp. 10/31/15 141216442 exp. 1/31/16 150116443 exp. 1/31/16 150317819 exp. 3/31/16 150317820 exp. 3/31/16 150117018 exp. 4/30/16 150518692 exp. 5/31/16 150418356 exp. 5/31/16

Product
LAPAROSCOPY-COLORECTAL SURGICAL PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing…
Recalling firm
Customed, Inc
Quantity
354
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