Agency classClass IOur severity:Severe FDA (Devices)·Z-1159-2013·Announced 2013-05-08

Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

Hospira Inc. is recalling GemStar infusion pumps because low battery levels can corrupt history logs and cause an error that prevents the device from being used.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class I, which per the rubric mandates a minimum score of 4 (Severe), even though no injuries or deaths are reported in the source text.

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 affects pumps with List Numbers 13000, 13100, and 13150, which were distributed worldwide, including in the United States, Canada, Australia, and numerous countries in Europe, Asia, and the Middle East.

The recall is due to a defect where battery levels lower than 2.4 volts can result in a corrupt history log and loss of data for preview therapy parameters. This issue causes an 11/004 error, which results in the pump not being able to be used. The source text does not report any illnesses, injuries, or deaths associated with this defect.

Consumers and healthcare providers should stop using the affected pumps and contact Hospira Inc. for instructions on how to proceed. The recall is classified as FDA Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death, although no such events are reported in the provided text.

The recalled product

Product: GemStar Pump - Battery Product Usage: 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…
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump
Hazard: data-loss
device-malfunction

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: 13000
13100
13150

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.

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Same hazard · data loss