Date Recall Initiated |
August 15, 2007 |
---|---|
Product: |
Baxter Upgraded Colleague CX Single Channel Volumetric Infusion Pumps, model number 2M8161. Serial numbers include: 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, 15075103CC, 15075371CC |
Use: |
Electronic infusion pumps deliver controlled amounts of medications or other fluids to patients through an intravenous (IV), intra-arterial (IA), epidural, and other acceptable routes of administration. |
Recalling Firm: |
Baxter Healthcare Corp. Rt. 120 & Wilson Rd. Round Lake, IL 60073 |
Reason for Recall: |
A field service technician did not perform all of the hardware Recall: upgrades required in accordance with Baxter’s corrective action procedures related to eight open Colleague recalls. The service technician certified in the service documentation that the upgrades were done on the affected pumps even though the upgrades were not done. These incomplete upgrades were performed from May 22, 2007, through August 7, 2007. |
Public Contact: |
Customers may call Baxter Healthcare Corp. at 1-800-422-9837 |
FDA District: |
Chicago |
FDA Comments: |
On August 15, 2007, Baxter notified their customers that some of the Colleague pumps may not have been upgraded. The primary users of this device are hospitals. The company requested their customers to locate the affected pumps, take them out of service and notify Baxter to schedule a reinspection and servicing of the pumps. Class 1 recalls are the most serious type of recall and involve
|
Updated September 25, 2007
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH