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U.S. Department of Health and Human Services

Class 2 Device Recall CENTURION INTRODUCER BUNDLE,

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 Class 2 Device Recall CENTURION INTRODUCER BUNDLE,see related information
Date Initiated by FirmMarch 31, 2011
Date PostedMay 27, 2011
Recall Status1 Terminated 3 on September 13, 2011
Recall NumberZ-2315-2011
Recall Event ID 58346
Product Classification Kit, i.V. Start - Product Code LRS
ProductMaterial CVI3435, INTRODUCER BUNDLE, CENTURION INTRODUCER BUNDLE, REORDER CV13435, STERILE, LATEX FREE, CENTURION MEDICAL PRODUCTS CORP. WILLIAMSTON MI 48895, USA 800.248.4058 www.centurionmp.com FACILITATES LINE INSERTION
Code Information BATCHES 2010060450, 2010081250 AND 2010090750. 
Recalling Firm/
Manufacturer		 Centurion Medical Products Corporation
100 Centurion Way
Williamston MI 48895-9086
For Additional Information ContactLisa 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
ActionCenturion 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 Commerce30
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
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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