Reported Jan 10, 2018 · Terminated

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

Smiths Medical ASD Inc.

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: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690

Is this the product you have?

    • CADD-Legacy 1
    • Model 6400 Ambulatory Infusion Pump
    • REF 21-6400-51
    • PC 10008552-001
    • Smiths Medical ASD
    • Inc. Rx ONLY
Lot codes and dates
  • Serial Numbers
    • 409963
    • 409964
    • 409965
    • 409966
    • 409967
    • 409968
    • 409969
    • 409970
    • 409971
    • 409972
    • 409973
    • 409974
    • 409975
    • 409976
    • 409977
    • 409978
    • 409979
    • 409980
    • 409981
    • 409982
    • 409983
    • 409984
    • 409985
    • 409986
    • 409987
    • 409988
    • 409989
    • 409990
    • 409991
    • 409992
    • 409993
    • 409994
    • 409995
    • 409996
    • 409997
    • 409998
    • 409999
    • 410000
    • 410001
    • 410002
    • 410003
    • 410004
    • 410005
    • 410006
    • 410007
    • 410008
    • 410009
    • 410010
    • 410011
    • 410012
    • 410013
    • 410014
    • 410015
    • 410016
    • 410017
    • 410018
    • 410019
    • 410020
Amount recalled
58 units

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Why it was recalled

Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 25, 2020 · Data as of Sep 19, 6:06 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.