WalkMed Infusion, LLC recalls The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper…

Recall date

June 14, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2220-2016

FDA classification

Class II

Brand / firm

WalkMed Infusion, LLC

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.