FDAClass IDecember 10, 2014

Wound Management Tray Ill recall: Sterility Concern

Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals…

Why was Wound Management Tray Ill recalled?

Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.

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?

Lot numbers: 112020506 112030882 112062454 112093946 112114888 113047160 113068174 113109854 131210826 140211849 140412693 140613605 140915161

Product
Wound Management Tray Ill, Catalog number 900-540. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
Recalling firm
Customed, Inc
Quantity
13680
Distribution
US Distribution to Florida, New York and Puerto Rico..
Recall date
December 10, 2014
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls