Recall Z-0219-2023— Carefusion 2200 Inc
Class II · Ongoing
Class II FDA medical device recall by Carefusion 2200 Inc, initiated 2022-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST. 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
Product description
CareFusion V.Mueller GENESIS LARGE, CONTAINER 28 X 11" (71.1 X 27.9CM) 6" (15.2CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-61ST
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.