Cl II Triton Infusion Pump

Company: WalkMed Infusion LLC
Date of Enforcement Report 7/27/2016
Class lI:

PRODUCT

Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000)The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Recall Number Z-2219-2016

REASON
WalkMed Infusion, LLC Announces a Voluntary Field Action of the Triton Infusion Pump (model 300000) and Triton FP Infusion Pump (model 400000) Due to Unapproved Changes to the Software and Specifications of the Triton Infusion Pump (model 300000) and Unapproved Changes to the Intended Use of the Triton FP Infusion Pump (model 400000).

RECALLING FIRM/MANUFACTURER
WalkMed Infusion, LLC, Englewood, CO on 6/14/2016 Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2482 units

DISTRIBUTION
Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.

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Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.