Recall Z-2262-2024— CareFusion 303, Inc.

Name: FDA recall Z-2262-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-21

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2024-05-21. It names one FDA 510(k) clearance: K211218. Product: BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units. Reason: Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-21
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211218 — BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.·cleared 2023-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units

Reason for recall

Due to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server.

Data sourced from openFDA. This site is unofficial and independent of the FDA.