FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
- Recall number
- Z-0931-2014
- Recalling firm
- CareFusion 303, Inc.
- Product
- Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
- Status
- Terminated
- Initiated
- 2014-01-16
- Posted
- 2014-02-04
- Terminated
- 2014-08-06
- Reason
- 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.
- Root cause
- 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
- 9,550 units
- Distribution
- Nationwide in US and Canada
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K051499"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28