FDA-Device2018-01-10Class II

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.
Hazard

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.

Sold states
US, Australia
Affected count
58 units
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2018

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