Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
FDA Recall Z-0931-2014 · Posted 2014-02-04
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Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2014-01-16
Date Terminated2014-08-06
Product Quantity9,550 units
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.
Firm 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, [email protected], or technical support at (888) 812-3229.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide in US and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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