Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division,
FDA device recall Z-1037-2009 · posted 2009-03-02 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter has identified failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the Colleague Infusion Pumps.
- Action taken
- Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 221,097 pumps
- Distribution
- Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador,
- Date initiated
- 2009-01-23
- Date posted
- 2009-03-02
- Date terminated
- 2011-10-04
- 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 |