Baxter Colleague CX Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Divisio
FDA device recall Z-1224-2007 · posted 2007-09-19 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Some of the pumps were upgraded by one service technician who failed to replace prisms and batteries as required in the upgrade.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 42 pumps
- Distribution
- Florida and California
- Date initiated
- 2007-08-15
- Date posted
- 2007-09-19
- Date terminated
- 2008-02-21
- Location
- Round Lake, IL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163 (K063696) | Baxterhealthcare, Inc. | 2007-02-27 |