Z-1116-2013Class II

The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in...

Name: Z-1116-2013 The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in...
Creator: Hospira Inc.
Published: 2013-03-21
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-03-21 / Terminated / root cause: manufacturing process

FDA source

Hospira Inc. began a recall of The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is... on 2013-03-21. FDA classified it as Class II and gives the reason as "During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion". 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-1116-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-21
Posted: 2013-04-15
Terminated: 2016-08-29
Recalling firm: Abbott Medical
Product: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two disposable AA alkaline batteries. When powered by batteries, The GemStar Pump is ideal for ambulatory patients.
Product code: FRN Pump, Infusion
Reason for recall: During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Hospira sent an Urgent Device Field Correction letter dated March 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refrain from using the affected produc and contact Hospira at 1-800-441-4100 to arrange for return of their device for repair. Customers were directed to notify their customers if they further distributed the product and confirm they have done so by return of the reply form to Stericycle. For questions regarding this recall call 224-212-4892.
Quantity in commerce: 1) List Number 13000: 25,119 pumps; 2) List Number 13100: 185 pumps; 3) List Number 13150: 13,497 pumps
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Australia, New Zealand, China, Hong Kong, Taiwan, Japan, Korea, Philippines, Thailand, Malaysia, Canada, Austria, Bahrain, Belgium, Croatia, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Luxembourg, Malta, Netherlands, Norway, Oman, Portugal, Qatar, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, UK, United Arab Emirates, Brazil, Chile and Colombia.
Product codes and lots: List Numbers: 13000, 13100, 13150

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1116-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15
Z-1117-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-24	2013-04-15

Product code FRN

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)