Reported Jul 27, 2016 · Terminated

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

WalkMed Infusion, LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: WalkMed Infusion, LLC · 6555 S Kenton St Ste 304 · Englewood, CO · 80111-6838

Is this the product you have?

  • The pump (with cushioning foam inserts) is packaged in a single pump box. Four pump boxes are placed in an over-shipper for distribution.
Lot codes and dates
  • 2,482 of 2,482 codes

    • TR1041
    • TR1043
    • TR1044
    • TR1047
    • TR1049
    • TR1051
    • TR1053
    • TR1054
    • TR1055
    • TR1056
    • TR1058
    • TR1059
    • TR1060
    • TR1061
    • TR1062
    • TR1063
    • TR1064
    • TR1065
    • TR1066
    • TR1067
    • TR1068
    • TR1069
    • TR1070
    • TR1071
    • TR1072
    • TR1073
    • TR1074
    • TR1077
    • TR1078
    • TR1079
    • TR1080
    • TR1081
    • TR1082
    • TR1083
    • TR1084
    • TR1085
    • TR1086
    • TR1087
    • TR1088
    • TR1089
    • TR1090
    • TR1091
    • TR1093
    • TR1094
    • TR1095
    • TR1096
    • TR1097
    • TR1099
    • TR1100
    • TR1101
    • TR1102
    • TR1105
    • TR1106
    • TR1107
    • TR1109
    • TR1110
    • TR1111
    • TR1113
    • TR1114
    • TR1115
Amount recalled
2482 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

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).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 28, 2017 · Data as of Sep 19, 5:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.