Recall Z-0203-2023— Carefusion 2200 Inc

Name: FDA recall Z-0203-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-26

Class II · Ongoing

Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2022-09-26. It names one FDA 510(k) clearance: K142529. Product: CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST. Reason: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing..

Recalling firm: Carefusion 2200 Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-09-26
Firm location: Vernon Hills, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142529 — Genesis Reusable Rigid Container SystemCarefusion 2200, Inc.·cleared 2015-01-08

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

CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2" (26.7X19.0CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD0-3ST

Reason for recall

Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

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