Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication D
FDA device recall Z-0744-2012 · posted 2012-01-13 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter's Service Center did not perform the ground impedance and leakage current test which verify if any power overflow occurs and that it is properly discharged through the device electrical system.
- Action taken
- Baxter sent service technicians to the consignees location on July 14, 2010 and October 6, 2010 and conducted the ground impedance and leakage current test on the affected pumps. The pumps were found with specifications.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 2 units
- Distribution
- Nationwide distribution: Puerto Rico.
- Date initiated
- 2010-07-14
- Date posted
- 2012-01-13
- Date terminated
- 2012-01-13
- Location
- Round Lake, IL
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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 |