The Recall Desk
HighFDA (Devices)·Z-1512-2014·Announced 2014-05-07

Hospira Recalls GemStar Docking Stations Due to Power and Voltage Issues

Hospira is recalling GemStar Docking Stations because they may cause infusion pumps to fail to power up or stop infusions due to voltage errors.

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 where the pump may stop infusions or fail to power up, posing a risk of harm to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Hospira Inc. is recalling the GemStar Docking Station, used with GemStar infusion pumps, due to two potential safety issues. The recall covers 26,765 docking stations worldwide, including 6,866 units in the United States.

The first issue occurs when the Docking Station is used with a GemStar Phase 3 pump, where the pump may fail to power up while connected. The second issue occurs when a GemStar Phase 3 or Phase 4 pump is used with both the Docking Station and an External Battery Pack; the pump may display error code 11/003 and alarm for excessive input voltage. If the pump detects more than 3.6 Volts on the external voltage input, it will stop the infusion and trigger audible and visual alarms.

The affected products were distributed worldwide, including in the United States, Canada, and various countries in Europe, Asia, and the Middle East. Users should contact Hospira for further instructions on how to address these issues.

The recalled product

Product
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump for general infusions. List Numbers: 13075-XX-XX.
Manufacturer
Hospira Inc.

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 (9)

  • *** US DOCKING STATIONS *** List Numbers: 13075-04-01
  • 13075-04-03
  • 13075-04-05
  • 13075-04-07
  • 13075-04-09. *** FOREIGN DOCKING STATIONS *** List Numbers: 13075-24-01
  • 13075-24-03
  • 13075-24-05
  • 13075-24-07
  • 13075-92-09.

Distribution