Z-2707-2011

MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C

Name: Z-2707-2011 MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C
Creator: Carefusion 303, Inc.
Published: 2011-04-20
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2011-04-20 / Terminated / root cause: design

FDA source

Carefusion 303, Inc. began a recall of MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer... on 2011-04-20. The reason FDA records is "Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2707-2011
Status: Terminated
Initiated: 2011-04-20
Posted: 2011-06-29
Terminated: 2011-11-28
Recalling firm: CareFusion 303, Inc
Product: MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Carefusion has initiated a product recall for the MaxPlus bifuse extension set (minibore) needleless connectors Model MP9232-C as a result of a potential for occlusion. The product may be occluded at the bifused component.
Root cause tag: design
FDA root cause: Device Design
Action: CareFusion initiated on May 3, 2011, two distinctive "URGENT MEDICAL DEVICE RECALL NOTIFICATION" via mail delivery, to all affected customers and distributors. The notices identified the product, the problem, and the actions to be taken. Customers were instructed to 1.) Immediately complete and return the enclosed pre-addressed and postage paid Recall Response Card to CareFusion. Note on the card your distributor, the MaxPlus bifuse extension set lot numbers and quantities that will be returned. 2.) All recalled product should be returned directly to the distributor from whom it was purchased. Customers will receive their return goods number through their distributor or CareFusion. 3.) Also, enclosed is a Frequently Asked Question (FAQ) Letter to address any questions or concerns related to the use of the MaxPlus" bifuse extension sets. The second notification was specifically addressed to distributors. The distributors were provided specific instructions for product returned. For customers who may have questions, please contact your distributor directly, or call the CareFusion Support Center at 1-800- 562-6018. The Support Center will be in operation from 7 a.m. - 4 p.m. PST. For distributors who may have any questions or require additional materials, please contact the CareFusion Support Center at 1800- 562-6018. Additionally, instructions were given to report adverse reactions experienced via the FDA's Med Watch Program.
Quantity in commerce: 26,150 units
Distribution: Nationwide Distribution -- USA including states of: CA, IA, IN, and TX
Product codes and lots: Lot Numbers: 10128001, 11018001, 11018002, 11018003, 11018007, 11018012, 11018013.

Product code FPA

K051499Class IIIntravascular Administration Set and Extension SetMedegen Medical Manufacturing Services / cleared 2005-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)