| | Class 1 Recall
Volumetric Infusion Pump |  |
| Date Posted |
November 05, 2010 |
| Recall Number |
Z-0307-2011 |
| Product |
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. |
| Code Information |
Serial numbers: 1 thru 500, TR1041 through TR2559.
|
Recalling Firm/
Manufacturer |
Walkmed Infusion LLC
96 Inverness Dr E Ste N
Centennial, Colorado 80112-5311 |
| Consumer Instructions |
Discard product or return to place of purchase for a full refund or exchange |
Reason for
Recall |
Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
|
| 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 made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933. |
| Quantity in Commerce |
1565 pumps |
| Distribution |
Nationwide Distribution -- AL, CA, FL, and PA. |
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