Cl II WalkMed Infusion Triton Infusion Pump

Company:.WalkMed Infusion, LLC.
Date of Enforcement Report 12/16/2015
Class lI:

PRODUCT

WalkMed Infusion Triton Infusion Pump (model 300000). Packaged in a single pump box. Four pump boxes are place in an over-shipper for distribution.
Recall Number Z-0369-2016

REASON
WalkMed Infusion is conducting a field action on the Triton Infusion Pumps (model numbers 300000 and 400000) because of the potential for the device to deliver more than 25% over the target infusion rate.

RECALLING FIRM/MANUFACTURER
WalkMed Infusion, LLC, Englewood, CO, on 11/3/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2567

DISTRIBUTION
Nationwide. No foreign or military/govt/VA consignees.

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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