FDAClass IISeptember 9, 2015

LAPAROSCOPY PK 3/CS Used by medical staff to perform recall

LAPAROSCOPY PK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate…

Why was LAPAROSCOPY PK 3/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?

Catalog number:900028 Lots: 141015610 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 140814877 exp. 10/31/15 150116717 exp. 1/31/16 150116716 exp. 10/31/15 150116715 exp. 10/31/15 150116719 exp. 1/31/16 150116714 exp. 10/31/15 150116718 exp. 1/31/16

Product
LAPAROSCOPY PK 3/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
339 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