Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for del

FDA device recall Z-1122-2014 · posted 2014-03-03 · Terminated

Recall details

Recalling firm

WalkMed Infusion, LLC

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.

Action taken

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

Status

Terminated

Product code

FRN

Quantity affected

797

Distribution

US Distribution including the states of IL, MA, KS, and, NJ.

Date initiated

2014-02-17

Date posted

2014-03-03

Date terminated

2014-10-06

Location

Englewood, CO

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