FDAClass IISeptember 9, 2015

MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical recall

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

Why was MINOR LACERATION TRAY CUSTOMED 50/CS Used by medical 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:9001765 Lots: 150116691 exp. 1/31/16 150217236 exp. 2/28/16 150418228 exp. 4/30/16 150317699 exp. 4/30/16 150518603 exp. 5/31/16 150518603 exp. 5/31/16 150518603 exp. 5/31/16

Product
MINOR LACERATION TRAY 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
2750
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