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.
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: "There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List…"
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
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