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U.S. Department of Health and Human Services

Class 2 Device Recall Trifuse Extension Sets

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  Class 2 Device Recall Trifuse Extension Sets see related information
Date Initiated by Firm January 16, 2014
Date Posted February 04, 2014
Recall Status1 Terminated 3 on August 06, 2014
Recall Number Z-0931-2014
Recall Event ID 67326
510(K)Number K051499  
Product Classification Set, administration, intravascular - Product Code FPA
Product Trifurcated Extension Set, model no. ME 1224.
Trifurcated Extension Set, model no. MP 9230.
Code Information Trifurcated Extension Set, Model No. ME 1224,  Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002  Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-4000
Manufacturer Reason
for Recall		 CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action A customer notification letter and a distribution letter are dated 1/22/14 were sent to customers to inform them that CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230 may have a defect in the trifurcated component that could result in the component to leak. The letters inform the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclose, pre-addressed and postage paid, recall response card. Customers are instructed that once CareFusion receives the recall response card, the CareFusion Support Center will provide instructions for return of the affected lot number and replacement of the affected lot. Customers are instructed to contact CareFusion Support Center at (888) 562-6018, Customer advocacy at (888) 812-3266, customerfeedback@carefusion.com, or technical support at (888) 812-3229.
Quantity in Commerce 9,550 units
Distribution Nationwide in US and Canada
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = MEDEGEN MEDICAL MANUFACTURING SERVICES
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