FDA Device recall Z-0421-2015
GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 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 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0421-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-19 |
| Published | 2014-12-03 |
| 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. 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
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
Identifiers
| code_info | List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers |
|---|
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-0421-2015%22
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