Aug

2020

Recall – Software error may lead to incorrect bolus delivery, Class I

Jordan Pate

News

recall, softwareerror

Company: Smiths Medical ASD Inc.
Date of Enforcement Report: 8/12/2020
Class I

PRODUCT

CADD Medfusion Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Recall Number: Z-2734-2020

REASON

Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.

RECALLING FIRM/MANUFACTURER

Smiths Medical ASD Inc. on 6/26/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

35616 units

DISTRIBUTION

International

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Recall – Software error may lead to incorrect bolus delivery, Class I

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