Z-0095-2015Class I

The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching...

Name: Z-0095-2015 The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching...
Creator: Hospira Inc.
Published: 2014-02-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-02-03 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts... on 2014-02-03. FDA classified it as Class I and gives the reason as "The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0095-2015
Classification: Class I
Status: Terminated
Initiated: 2014-02-03
Posted: 2014-10-24
Terminated: 2017-03-07
Recalling firm: Abbott Medical
Product: The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an output to the device of 3.3 Volts DC.
Product code: FRN Pump, Infusion
Reason for recall: The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE CORRECTION letter dated February 3, 2014 was sent to all direct accounts. The letter included specific instructions for how to handle and use the power supplies so as to minimize the chance of any device failures. There were additional instructions for customers to: 1) Inform potential users in their organization of the product of this notification; 2) Complete the attached reply form and return it to the fax number or e-mail address on the form (even if you do not have any affected product in inventory); 3) If the products were further distributed, their customers should be notified of the recall and asked to contact Stericycle at 888-641-9735 to receive a reply form; and, 4) if a potential user believes that their power supply is damaged for any reason, it should be removed from service and the user should contact Hospira Global Complaints at 800-441-4100 to report the concern. The letter further notes that there is no need to return fully functional power supplies (unless they malfunction).
Quantity in commerce: 978 power supplies
Distribution: Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and, the countries of Austria, Belgium, Brazil, Columbia, France, Germany, Greece, Netherlands, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Product codes and lots: Wall Mount GemStar Power Supply List Number: 13026; Lot Numbers: 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, 27296G1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0095-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0095-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24
Z-0096-2015	Class I	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-24

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)