| Class 2 Device Recall CENTURION CVC ACCESSORY KIT | |
Date Initiated by Firm | March 31, 2011 |
Date Posted | May 27, 2011 |
Recall Status1 |
Terminated 3 on September 13, 2011 |
Recall Number | Z-2322-2011 |
Recall Event ID |
58346 |
Product Classification |
Kit, i.V. Start - Product Code LRS
|
Product | Material DT11520, CVC ACCESSORY KIT, CENTURION CVC ACCESSORY KIT, REORDER DT11520, STERILE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895 USA 800.248.4058 www.centurionmp.com
FACILITATES LINE INSERTION |
Code Information |
BATCHES 2009102650, 2009120850, 2009122950, 2010031750, 2010040850, 2010052550, 2010062250, AND 2010081250. 2010092150 |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
|
For Additional Information Contact | Lisa Carpenter 517-546-3356 |
Manufacturer 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. |
FDA Determined Cause 2 | Material/Component Contamination |
Action | 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. |
Quantity in Commerce | 800 |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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