Agency classClass IOur severity:Severe FDA (Devices)·Z-0095-2015·Announced 2014-11-05

Hospira Recalls GemStar Power Supplies Due to Power Delivery Failure

Hospira is recalling 978 GemStar Power Supplies because they may fail to provide power to the infusion pump, resulting in smoke.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency 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 supply."

Plain-English summary

Hospira Inc. is recalling 978 GemStar Power Supplies, which are accessories for the GemStar Infusion Pump. The power supplies are two-piece assembled switching units that convert alternating current (AC) line input voltage of 120 or 240 V to an output of 3.3 Volts DC for the device.

The recall was initiated because the GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one reported instance, smoke was observed, and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply.

The affected units were distributed worldwide, including in the United States and various international countries. The specific lot numbers involved are 25283G1, 26286G1, 26287G1, 27292G1, 27294G1, 27295G1, and 27296G1, with a list number of 13026. Users should check their power supplies for these identifiers and contact the manufacturer for instructions.

The recalled product

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.
Manufacturer: Hospira Inc.
Category: Medical Device — Infusion Pump Accessory
Hazard: power-failure
smoke
Affected units: 978

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 (8)

Wall Mount GemStar Power Supply List Number: 13026
Lot Numbers: 25283G1
26286G1
26287G1
27292G1
27294G1
27295G1
27296G1

Distribution

Distributed in 49 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 · power failure