GemStar infusion pump — Class II medical device recall Z-0422-2015
Terminated recall by Hospira Inc., reported 2014-12-03, distributed nationwide. Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusi
| Recall number | Z-0422-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2013-03-19 |
| Classified | 2014-11-23 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-09-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CH, DE, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IT, JO, KR, KW, LB, LU, MT, NL, NZ, OM, PT, QA, RO, SA, SE, SI, TR, TW, ZA |
Product
GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products. The epidural route is recommended to provide anesthesia or administer analgesia for periods up to 96 hours. ..
Reason for recall
Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Service Manual should be removed from these w
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-0422-2015. 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.