Recall Z-3139-2024— CareFusion 303, Inc.

Name: FDA recall Z-3139-2024
Creator: U.S. Food and Drug Administration
Published: 2024-08-15

Class II · Ongoing

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2024-08-15. It names one FDA 510(k) clearance: K211218. Product: Alaris PCA Module Model 8120, a modular infusion pump and monitoring system. Reason: Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-08-15
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

Alaris PCA Module Model 8120, a modular infusion pump and monitoring system

Reason for recall

Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

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