Material DT11520, CVC ACCESSORY KIT, CENTURION CVC ACCESSORY KIT, REORDER DT11520, STERILE, CENTURION MEDICAL PRODUCTS C

FDA device recall Z-2322-2011 · posted 2011-05-27 · Terminated

Recall details

Recalling firm

Centurion Medical Products Corporation

Reason for recall

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.

Action taken

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.

Root cause

Material/Component Contamination

Status

Terminated

Product code

LRS

Quantity affected

800

Distribution

Nationwide Distribution

Date initiated

2011-03-31

Date posted

2011-05-27

Date terminated

2011-09-13

Location

Williamston, MI