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

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

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.