Data Foundry

Medical device recalls 2016

Alaris PC Unit — Class II medical device recall Z-1239-2016

Terminated recall by CareFusion 303, Inc., reported 2016-03-30, distributed nationwide. CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System

Recall numberZ-1239-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCareFusion 303, Inc., San Diego, CA, United States
Recall initiated2016-02-12
Classified2016-03-24
Reported by FDA2016-03-30
Terminated2017-06-23
DistributedNationwide (US)
Quantity170 units
Serial numbers12351849, 12409069, 12426138, 12475162, 12498854, 3606478, 4020663, 4021398, 4043375, 4043745, 4044531, 4044845, 4045659, 4058193, 4063430, 4063830, 4063911, 4064030, 4064411, 4093501, 4094994, 9899143, 9907675, 9922622, 9925068 and 3 more
Model numbers8000, TC10005092

Product

Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092

Reason for recall

CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630).

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-1239-2016. 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.