The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device accessory that failed to provide power, resulting in smoke and reliance on battery backup. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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.
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

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 →