Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
FDA device recall Z-0598-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.
- Action taken
- Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- one pump
- Distribution
- Puerto Rico
- Date initiated
- 2009-05-08
- Date posted
- 2012-01-11
- Date terminated
- 2012-01-03
- 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 |