The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0096-2015·Announced 2014-11-05

Hospira Recalls GemStar Power Supply Due to Power Delivery Failure

Hospira is recalling GemStar Power Supplies because they may fail to provide direct current power to the infusion pump, potentially causing 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 the GemStar Power Supply, an accessory for the GemStar Infusion Pump. The power supply is a two-piece assembled switching unit that converts alternating current (AC) line input voltage of 120 or 240 V to an output of 3.3 Volts DC for the device.

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

The recall affects 4,709 power supplies distributed in the United States and 7,425 power supplies distributed in foreign countries. The products were distributed worldwide, including in the United States and various countries in Europe, South America, Africa, and the Middle East. Consumers and healthcare facilities should stop using the affected power supplies and contact Hospira Inc. for instructions on replacement or return.

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

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 (20)

  • Desktop GemStar Power Supply List Number: 13072-05
  • 1) US Distribution Lot Numbers: 10115G1
  • 11121G1
  • 11122G1
  • 1123G1
  • 11124G1
  • 12143G1
  • 12144G1
  • 12178G1
  • 15185G1
  • 12195G1
  • 17214G1
  • 18217G1
  • 18219G1
  • 19225G1
  • 20233G1
  • 21242G1
  • 22251G1
  • 23259G1
  • 24271G1

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 →

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