WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as p
FDA device recall Z-0307-2011 · posted 2010-11-05 · Terminated
Recall details
- Recalling firm
- Walkmed Infusion LLC
- Reason for recall
- Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
- Action taken
- All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 1565 pumps
- Distribution
- Nationwide Distribution -- AL, CA, FL, and PA.
- Date initiated
- 2010-06-17
- Date posted
- 2010-11-05
- Date terminated
- 2012-03-14
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFF (MARK I) VOLUMETRIC INFUSION PUMP (K070529) | Definitive Medical Technologies, Ltd. | 2007-05-08 |