September 19, 2005-All models of Baxter Healthcare Corp COLLEAGUE® Volumetric Infusion Pumps. Affected Models were: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, and 2M8163R.
These electronic infusion pumps were used to give controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural or other direct line into the bloodstream.
The pump’s batteries have been known to experience battery swelling and/or excessive discharge failures. Both of these failures will result in irreversible damage to the battery. If either one of these failures occurs, the pump would be incapable of operating on battery power for the expected amount of time, thus leading to interruption or prevention of therapy and the possible death and/or serious injury of patients.
June 21, 2007-Baxter Colleague ® and FLO-GARD ® Volumetric Infusion Pumps
- COLLEAGUE ® Mono Single Channel Volumetric Infusion Pump; Product Code 2M8151
- COLLEAGUE ® CX Single Channel Volumetric Infusion Pump; Product Code 2M8161
See: Recall for Colleague and Colleague CX Infusion Pumps for the list of serial numbers
- COLLEAGUE ® Mono Triple Channel Volumetric Infusion Pump; Product Code 2M8153
- COLLEAGUE ® CX Triple Channel Volumetric Infusion Pump; Product Code 2M8163
See also: June 20, 2007, Recall for Baxter Upgraded COLLEAGUE ® Triple Channel Volumetric Infusion Pumps
- FLO-GARD ® 6201, Single Channel Volumetric Infusion Pump; Product Code 2M8063
See: Recall for Baxter FLO-GARD 6201 Volumetric Infusion Pumps for the list of serial numbers
- FLO-GARD ® 6301, Dual Channel Volumetric Infusion Pump; Product Code 2M8064
From April, 2006 through February, 2007, Baxter distributed 534 pumps to 180 customers (including distributors, medical facilities, retail companies and one institution) within the U.S. On August 3, 2007, Baxter expanded the electrical data recall to include an additional 986 Colleague Pumps to 178 customers within the US.
The reason for the recall: Baxter Healthcare identified repair, inspection and test data sheets, which included electrical safety data, for the pumps, that were falsified.
Baxter Healthcare is no stranger to recalls.
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