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