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Terminated

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

FDA Recall Z-0307-2018 · Posted 2018-01-02

Recalling FirmSmiths Medical ASD Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-11-22
Date Terminated2020-09-25
Product Quantity58 units

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.

Firm Action

The recall notices were disseminated via FedEx to US consignees on November 22, 2017. The recall notices were disseminated via email to Australian consignees on November 27, 2017. The consignee was directed to turn on the pump and check the serial against the serial number on the label. If they did not match, then they were directed to return the unit.

Root Cause

Process design

Distribution Pattern

US, Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982838CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400Sims Deltec, Inc. · 1998-11-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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