Data Foundry

Medical device recalls 2013

GemStar Pump — Class I medical device recall Z-1159-2013

Terminated recall by Hospira Inc., reported 2013-05-08, distributed nationwide. Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's param

Recall numberZ-1159-2013
Product typeMedical device
ClassificationClass I
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHospira Inc., Lake Forest, IL, United States
Recall initiated2013-03-18
Classified2013-04-26
Reported by FDA2013-05-08
Terminated2017-03-07
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, BH, BR, CA, CH, CL, CN, CO, DE, DK, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LB, LU, MT, MY, NL, NO, NZ, OM, PH, PT, QA, RO, SA, SE, SI, TH, TR, TW, ZA

Product

GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.

Reason for recall

Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used.

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-1159-2013. 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.