Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division,
FDA device recall Z-0483-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- Baxter has identified the potential for a corruption of the memory chip in the pump to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user.
- Action taken
- Baxter sent the 12/6/06 Safety Alert letter to all Colleague Infusion Pump customers, to the attention of the Director of Radiation Oncology with copies to the Medical Physicist and Vice President of Nursing, via first class mail to advise them that the Colleague pump is not recommended for use in Linear Accelerator radiation therapy suites. The letters informed the users that there is a potential for a corruption of the memory chip to occur due to linear accelerator radiation exposure. If corruption occurs, it could result in an interruption of therapy with an audible and visual alarm notification to the user. The letter listed the error codes that may occur if the pump has been exposed to this type of radiation: 18:200, 18:416, 36:416, 19:113, 41:113, 314:432 and 302:435:XXXX:0006. If the pump displays any of the codes, the user was requested to submit the pump to their service facility. Failure code 199 may also occur and requires reconfiguration of the pump settings by the user's biomedical services organization. Any questions were directed to Baxter Global Technical Services at 1-800-843-7867, prompt 2.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 267,317 pumps
- Distribution
- Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland,
- Date initiated
- 2006-12-06
- Date posted
- 2007-01-11
- Date terminated
- 2011-06-30
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COLLEAGUE VOLUMETRIC INFUSION PUMPS (K041191) | Baxter Healthcare Corp | 2004-06-25 |