—#99120

Product

Material DT5035, PORT ACCESS TRAY, CENTURION PORT ACCESS TRAY, REORDER DT5035, STERILE..., CENTURION MEDICAL PRODUCTS CORP. HOWELL MI 48843 USA 800.248.4058 www.centurionmp.com FACILITATES DRESSING CHANGE

FDA product code: MCY — Wound Dressing Kit
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: BATCHES 2009122950 AND 2010081950. .

Why it was recalled

This voluntary sub-recall was initiated because the vials of Bacteriostatic Sodium Chloride Injection, USP, 0.9% utilized to make the products may contain visible particulates.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

Centurion Medical Products Corporation issued press on April 1, 2011, and sent an Urgent Voluntary Recall letter dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the kits immediately and instructions were provided for the return of the kits. Customers were also asked to complete a form to fax or email back to the firm regarding the number of kits the firm has in their possession. Customers were instructed to provide recall notification to other firm's who received the recalled kits from their direct account. For any questions regarding this recall call 631-924-4000, ext 142.

Recalling firm

Firm: Centurion Medical Products Corporation
Address: 100 Centurion Way, Williamston, Michigan 48895-9086

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-03-31
Posted by FDA: 2011-05-27
Terminated: 2011-09-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99120. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.