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

Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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Corporate Office

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