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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
Recalled July 27, 2016 · FDA recall Z-2220-2016 · WalkMed Infusion
Hazard
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). · FDA Class II
Units
2966 units
Sold at
Nationwide to AL, AZ, CA, FL, IL, KS, MA, MD, MS,NJ, OH, PA, TN, TX, UT, and WA. No foreign/VA/govt/military.
Description
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).
Product
The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Manufacturer(s)
WalkMed Infusion, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →