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.
FDA Recall Z-0307-2011 · Posted 2010-11-05
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Recalling FirmWalkmed Infusion LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-06-17
Date Terminated2012-03-14
Product Quantity1565 pumps
Reason for Recall
Pump door may be in a near shut position, but unlatched, and the "Door Open" alarm may not sound.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution -- AL, CA, FL, and PA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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