Agency classClass IOur severity:Critical FDA (Devices)·Z-1170-2013·Announced 2013-05-08

Hospira Recalls GemStar Infusion Pumps Due to Unexpected Shutdowns

Hospira Inc. is recalling GemStar infusion pumps because they may shut off during use without warning, potentially interrupting patient medication delivery.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Hospira Inc. is recalling GemStar infusion pumps, which are small, single-channel electronic infusion devices used in homes, hospitals, and other settings. The recall is being conducted because the pumps may shut off during use without warning.

The affected units are identified by List Numbers 13086, 13087, and 13088. The recall covers 286 pumps from List Number 13086, 45,376 pumps from List Number 13087, and 23,942 pumps from List Number 13088. These devices were distributed nationwide in the United States and internationally to numerous countries including Australia, Canada, and various nations in Europe, Asia, and the Middle East.

Consumers and healthcare providers should stop using the affected pumps and contact Hospira Inc. for instructions on how to proceed. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product could cause serious adverse health consequences or death.

The recalled product

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…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: device-malfunction
unexpected-shutdown

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

List Numbers: 13086
13087
13088

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Hospira Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Hospira Inc.

See all →

Critical
Hospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
Moderate
Hospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
Low
Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
Severe
Hospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
High
Hospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16

Same hazard · device malfunction