Recall – Infusion pump PC unit displays incorrect syringe type and size

Company: CareFusion 303, Inc.
Date of Enforcement Report: 9/16/2020
Class I

PRODUCT

BD Alaris System; Alaris PCA Model 8120; P/N P0000031; Rx Only. Infusion pump for Patient Controlled Analgesia.

Recall Number: Z-2882-2020

REASON

The Alaris PC unit to display incorrect syringe type and/or syringe sizes. This could potentially result in delays in infusion, under-infusion, or over-infusion.

RECALLING FIRM/MANUFACTURER

CareFusion 303, Inc. on 8/4/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

174,655 units

DISTRIBUTION

U.S. Nationwide and 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.