Data Foundry

Medical device recalls 2016

Alaris Pump VersaSafe Infusion Set — Class II medical device recall Z-1179-2016

Terminated recall by CareFusion 303, Inc., reported 2016-03-23, distributed in MI. CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSa

Recall numberZ-1179-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2016-02-15
Classified2016-03-17
Reported by FDA2016-03-23
Terminated2016-10-24
DistributedMI
Quantity5,760 units
Reason classespackaging
Lot numbers13085603
Model numbers2122-0007

Product

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

Reason for recall

CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

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-1179-2016. 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.