GemStar infusion pump — Class II medical device recall Z-2031-2014
Terminated recall by Hospira Inc., reported 2014-07-16, distributed nationwide. The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify t
| Recall number | Z-2031-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-01-31 |
| Classified | 2014-07-09 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2016-08-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, DE, ES, FR, GB, GR, GT, HK, IT, JO, KW, LB, LU, MX, MY, NL, OM, PT, SA, SI, TH, TR, TW, VE, ZA |
| Quantity | 36,881 infusion |
| Reason classes | device malfunction |
| Serial numbers | 12470045, 12470063, 12470085, 12470109, 12470130, 12470133, 12470135, 12470138, 12470144, 12470145, 12470147, 12470152, 12470153, 12470154, 12470156, 12470157, 12470158, 12470160, 12470162, 12470163, 12470164, 12470165, 12470167, 12470168, 12470169 and 475 more |
Product
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products.
Reason for recall
The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be returned to service.
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-2031-2014. 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.