—#55495

Product

Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; 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 numbers 14051565CC, 15034273CC, 15034492CC, 15040255CC, 15041116CC, 15041169CC, 15041170CC, 15041172CC, 15041181CC, 15041194CC, 15041199CC, 15041206CC, 15041212CC, 15041218CC, 15041241CC, 15041288CC, 15041290CC, 15041317CC, 15050020CC, 15050034CC, 15050045CC, 15050061CC, 15050080CC, 15050117CC, 15050129CC, 15060087CC, 15060217CC, 15060253CC, 15060479CC, 15060489CC, 15060549CC, 15060557CC, 15060600CC, 15060738CC, 15060790CC, 15060827CC, 15060939CC, 15060940CC, 15060968CC, 15063211CC, 15075371CC, 15075103CC

Why it was recalled

Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.

Root cause (FDA determination)

Other

Action the firm took

The affected hospitals were sent an Urgent Colleague Deployment Correction letter dated 8/15/07 via overnight mail. The hospitals were informed that some of the Colleague pumps at their facility may not have been completely upgraded to include all the necessary components required as part of Baxter's Corrective Action Plan (CAP). The hospitals were provided a list of affected pump serial numbers and were requested to remove the pumps from clinical use and notify all end users of the action. The accounts were requested to complete the enclosed customer reply form, acknowledging the receipt and understanding of the letter and fax it back to Baxter at 1-847-270-5457. The hospitals were also requested to report any malfunction or adverse event related to the Colleague Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176.

Recalling firm

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

Distribution

Distribution pattern: Florida and California

Timeline

Recall initiated: 2007-08-15
Posted by FDA: 2007-09-19
Terminated: 2008-02-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #55495. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.