Reported May 7, 2014 · Terminated
GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the…
Hospira Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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 Numbers13075-XX-XX
- Lot codes and dates
- *** US DOCKING STATIONS ***
- List Numbers13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-04-09. *** FOREIGN DOCKING STATIONS ***
- List Numbers
13075-24-0113075-24-0313075-24-0513075-24-0713075-92-09
- Amount recalled
- 26,765 docking stations total (6866 in US)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Stop using this product now
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 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to the Docking Station, and 2) when either a GemStar Phase 3 (List 13000-XX, 13100-XX, or 13150-XX)or GemStar Phase 4 pump (List 13086-XX, 13087-XX, or 13088-XX) is used in conjunction with both a Docking Station and an External Battery Pack accessory (List 13073-XX) there exists a possibility that the GemStar pump will display error code 11/003 and give an audible alarm indicating excessive input voltage from the external sources. If the GemStar pump detects what is perceived to be more than 3.6 Volts measured on the external voltage input, the pump will stop the infusion and alarm both with an audible sound as well as a visual alarm.
Using this product could cause serious injury, illness or death — stop using it now.
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