—#106433

Product

Wound Management Tray, catalog# 900-1456

FDA product code: MCY — Wound Dressing Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: lot# 111051053, 111051316, 111061635, 111082187, 111092568

Why it was recalled

The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.

Root cause (FDA determination)

Packaging

Action the firm took

Customed Inc sent an Urgent Medical Device Recall letter dated December 8, 2011 to distributors via e-mail; then by certified (return and receipt) mail. The letter identified the product, description of problem, and actions to be taken. The letter included the following instructions: 1. Product should be removed from sale (Quarantine them) and cease distribution. Products affected shall NOT be used. 2. Return the enclosed acknowledgement form to Customed, Inc. Recall Coordinator whether or not the consignee has affected products. 3. If products has been futher distributed, sub-recall products - It is extremely important to notify your customers of this action by including a copy of this leller along with your formal notification. Please, instruct your customer to follow your directions for credit/replacemenl if they purchased the product from you. For qucstions. contact Cuslomed, Inc. Recall Coordinator at 787-622-5151 Ext. 7510.

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

Distribution pattern: USA Nationwide Distribution - including Florida and Puerto Rico.

Timeline

Recall initiated: 2011-12-08
Posted by FDA: 2012-03-21
Terminated: 2017-04-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #106433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.