Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- December 1, 2010
- Posted
- January 21, 2011
- Terminated
- May 13, 2011
- Recall Number
- Z-0931-2011
- Quantity
- 1 pump
- Firm Location
- Round Lake, IL
Reason for Recall
While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.
Distribution
Texas
Lot / Code Info
Product Code: 2M8161, serial number 15030799CC
Root Cause
Employee error
Action Taken
Baxter telephoned the one customer on December 1, 2010, informing them that that an outgoing Quality Control Evaluation was not performed on their Colleague pump serial number 15030799CC during the last service. Since this was not conducted on this pump, the device may not function as designed and could lead to an interruption of therapy. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter will then send a shipping container for retrieval, reinspection and return of the device back to the customer at no cost. For questions regarding this recall call (800) 437-5176.