Medical device recalls Moderate risk

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

Recall date
November 22, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0307-2018
FDA classification
Class II
Brand / firm
Smiths Medical ASD Inc.
Sold / distributed
US, Australia

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.

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

What was recalled

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

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