—#96445

Product

Baxter Colleague Single Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K063696
Affected lot / code info: Product Code: 2M8161, serial number 15030799CC

Why it was recalled

While the infusion pump was being serviced at the Baxter Service Center, it was inadvertently routed to the packaging area before the final inspection.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Texas

Timeline

Recall initiated: 2010-12-01
Posted by FDA: 2011-01-21
Terminated: 2011-05-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.