||February 04, 2014
||Terminated on August 06, 2014
|Recall Event ID
Set, Administration, Intravascular - Product Code FPA
||Trifurcated Extension Set, model no. ME 1224.
Trifurcated Extension Set, model no. MP 9230.
||Trifurcated Extension Set, Model No. ME 1224,
Trifurcated Extension Set, Model No. MP 9230
Lot No. 13015666.
|CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
|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.
||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, email@example.com, or technical support at (888) 812-3229.
|Quantity in Commerce
||Nationwide in US and Canada
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = FPA and Original Applicant = MEDEGEN MEDICAL MANUFACTURING SERVICES