Data Foundry

Medical device recalls 2013

CareFusion Gravity Set — Class II medical device recall Z-2281-2013

Terminated recall by CareFusion 303, Inc., reported 2013-10-02, distributed in IL. CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected

Recall numberZ-2281-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2013-08-30
Classified2013-09-26
Reported by FDA2013-10-02
Terminated2013-12-26
DistributedIL
Quantity2,850 units
Reason classeslabeling
Lot numbers12086930, 12106215, 13016408, 13016834, 13025446, 13025672
Model numbers44000-07

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2281-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.