Recall Z-0307-2011 ยท FRN Pump, Infusion
Walkmed Infusion LLC
WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
| Date | Nov 5, 2010 (initiated Jun 17, 2010) |
| Status | Terminated |
| Reason | Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound. |
| Root cause | Device Design |
| Action | 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 |
| Quantity | 1565 pumps |
| Distribution | Nationwide Distribution -- AL, CA, FL, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070529 | AFF (MARK I) VOLUMETRIC INFUSION PUMP Definitive Medical Technologies, Ltd., May 8, 2007 |