Recall Z-0307-2018— Smiths Medical ASD Inc.

Name: FDA recall Z-0307-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-22

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2017-11-22, terminated 2020-09-25. It names one FDA 510(k) clearance: K982838. Product: CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY. Reason: 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..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-22
Terminated: 2020-09-25
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K982838 — CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400Sims Deltec, Inc.·cleared 1998-11-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.