Z-0421-2015Class II

GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number...

Name: Z-0421-2015 GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number...
Creator: Hospira Inc.
Published: 2013-03-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-03-19 / Terminated

FDA source

Hospira Inc. began a recall of GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for... on 2013-03-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0421-2015
Classification: Class II
Status: Terminated
Initiated: 2013-03-19
Posted: 2014-11-24
Terminated: 2016-09-09
Recalling firm: Abbott Medical
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. .
Product code: FRN Pump, Infusion
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
FDA root cause: Other
Action: Hospira sent a letters dated March 19, 2013 to Internet website sponsors to request removal of the GemStar User/Service Manual from their websites as soon as possible. The Internet website sponsors were requested to return a confirmation form after removing the GemStar User Service Manual from their site. For questions call 224-212-2891.
Quantity in commerce: Not Applicable
Distribution: Worldwide Distribution - US: Nationwide and the countries of Australia, Austria, Bahrain, Belgium, Croatia, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Icelanofd, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, New Zealand, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom
Product codes and lots: List Numbers: 13000, 13100, 13150; Serial Numbers: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0421-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0421-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-23
Z-0422-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-03	2014-11-23

Product code FRN

K060806Class IIHospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088Hospira, Inc. / cleared 2006-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)