Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0307-2018 — CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

U.S. FDA — Device Enforcement · United States · 2017-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0307-2018
Date of alert
2017-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Smiths Medical ASD Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10008552
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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