FDA Device Recalls

Recalls / —

—#99149

Product

Material ECVC270, CENTRAL LINE INSERTION BUNDLE, CENTURION CENTRAL LINE INSERTION BUNDLE, REORDER ECVC270, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES CENTRAL LINE INSERTION

FDA product code
LRS — I.V. Start Kit
Device class
Class 2
Medical specialty
General Hospital
Affected lot / code info
BATCHES 2009102350, 2009121750, 2010020350, 2010021050, 2010030150 AND 2010041250.                                                             2009100550, 2009111650, 2009121550, 2010021950, 2010040550, 2010060950 AND 2010062850.                                                                                                                                               .

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 #99149. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.