Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.
FDA Recall Z-1122-2014 · Posted 2014-03-03
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Recalling FirmWalkMed Infusion, LLC
Recall StatusTerminated
Product CodeFRN
Date Initiated2014-02-17
Date Terminated2014-10-06
Product Quantity797
Reason for Recall
WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect
instruction.
Firm Action
WalkMed Infusion sent an Important Medical Device Recall letter dated February 14, 2014, to all affected customers. The letter identified the product the problem and the action customers need to take.
Our records Indicate that you have purchased product affected by this recall (see the attached list).Our sales representative will contact you to determine a plan for label replacement for your units. Replacement of the label will include a simple process of removing the old label (PN 300063), replacing it with a corrected label(PN 400033) and documenting completion of the replacement. This action can be completed by you,your customers,our sales representative, or by returning the infusion pump to WalkMed Infusion.
For further questions please call (720) 351-4934 or (720) 351-4965.
Product will be corrected in the field when possible and supported by the customer. Otherwise, WalkMed Infusion employees with travel to the customer and complete the correction activities.
Root Cause
Labeling design
Distribution Pattern
US Distribution including the states of IL, MA, KS, and, NJ.
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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