PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 10, 2018 Initiated: November 22, 2017 #Z-0307-2018

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Smiths Medical ASD Inc.
Units Affected
58 units
Distribution
US, Australia
Location
Minneapolis, MN

Frequently Asked Questions

What product was recalled?
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY. Recalled by Smiths Medical ASD Inc.. Units affected: 58 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 10, 2018. Severity: Moderate. Recall number: Z-0307-2018.