Z-2281-2013Class II

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and...

Name: Z-2281-2013 CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and...
Creator: CareFusion 303, Inc.
Published: 2013-08-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2013-08-30 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the... on 2013-08-30. FDA classified it as Class II and gives the reason as "CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2281-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-09-26
Terminated: 2013-12-26
Recalling firm: CareFusion 303, Inc
Product: CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.
Product code: FPA Set, Administration, Intravascular
Reason for recall: CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: CareFusion sent an Urgent Medical Device Recall Notification letter dated August 30, 2013, to all affected customers to inform them that CareFusion is recalling the Gravity Set, Model 44000-07, Lot Numbers 12086930, 12106215, 13016408, 13016834, 13025446 and 13025672 as a result of an incorrect expiration date. The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and if they have questions then they are instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.
Quantity in commerce: 2,850 units
Distribution: IL
Product codes and lots: Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2281-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2281-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-26

Product code FPA

K820278Class IIIntravascular Administration SetY / cleared 1982-02-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)