FDA Device recall Z-2031-2014
GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150
- FDA Device
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150 by Hospira, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2031-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-31 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hospira |
| Distribution | US |
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
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.
Identifiers
| code_info | 1) List Number: 13000; Serial Numbers: 9221423 , 12470045 , 12470063 , 12470085 , 12470109 , 12470130 , 12470133…1) List Number: 13000; Serial Numbers: 9221423 , 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 , 12470171 , 12470172 , 12470173 , 12470174 , 12470177 , 12470180 , 12470207 , 12470208 , 12470209 , 12470220 , 12470225 , 12470239 , 12470243 , 12470244 , 12470257 , 12470258 , 12470259 , 12470262 , 12470268 , 12470273 , 12470279 , 12470281 , 12470283 , 12470285 , 12470290 , 12470294 , 12470299 , 12470301 , 12470303 , 12470304 , 12470305 , 12470319 , 12470320 , 12470321 , 12470332 , 12470335 , 12470337 , 12470338 , 12470340 , 12470341 , 12470346 , 12470347 , 12470350 , 12470354 , 12470357 , 12470360 , 12470361 , 12470362 , 12470365 , 12470366 , 12470367 , 12470369 , 12470370 , 12470375 , 12 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2031-2014%22
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