Agency classClass IOur severity:Severe FDA (Devices)·Z-1160-2013·Announced 2013-05-08

Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss

Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data 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 FDA has classified this as a Class I recall, which mandates a severity score of at least 4 according to the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to the device becoming unusable.

Plain-English summary

Hospira Inc. is recalling GemStar Pump batteries, which are used in single-channel infusion devices designed for home, hospital, or ambulatory use. The recall affects specific list numbers: 13086 (286 pumps), 13087 (45,376 pumps), and 13088 (23,492 pumps). The devices are 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 dropping below 2.4 volts result in a corrupt history log and loss of data for preview therapy parameters. This issue causes an 11/004 error, which renders the pump unusable. The FDA has classified this as a Class I recall.

Users of the affected GemStar pumps should stop using the devices and contact Hospira Inc. for further instructions on replacement or repair. The recall covers pumps powered by rechargeable battery packs or disposable AA alkaline batteries.

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: device-malfunction
data-loss

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.

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Same hazard · device malfunction