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