Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
FDA device recall Z-0931-2014 · posted 2014-02-04 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 9,550 units
- Distribution
- Nationwide in US and Canada
- Date initiated
- 2014-01-16
- Date posted
- 2014-02-04
- Date terminated
- 2014-08-06
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET (K051499) | Medegen Medical Manufacturing Services | 2005-06-22 |