Z-0216-2023Class II

CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE...

Name: Z-0216-2023 CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE...
Creator: Carefusion 2200 Inc
Published: 2022-09-26
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-09-26 / Open, Classified / root cause: sterility

FDA source

Carefusion 2200 Inc began a recall of CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST on 2022-09-26. FDA classified it as Class II and gives the reason as "Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0216-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-26
Posted: 2022-11-11
Recalling firm: Medtronic, Inc.
Product: CareFusion V.Mueller GENESIS SMALL, SHALLOW CONT. 21 X 7" (53.3 X 17.8CM) 3" (7.6CM) DEEP STERRAD COMPATIBLE, REF CD4-3ST
Product code: KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Reason for recall: Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: The firm disseminated URGENT MEDICAL DEVICE RECALL noticed on 10/04/2022 by Fed Ex 2-Day. The notices explained the issue and the hazard and requested the following: "1. Please check all inventory locations within your institution for the Product and immediately dispose of all affected Product remaining in your possession in accordance with your local facility s process. Please note the following materials for each component and dispose of them accordingly: Component: Container (bottoms, lids, retention plates), Material: Anodized aluminum 5000 and 1100 series, stainless steel 300 series Component: Gasket and handle grips, Material: Silicone Component: Baskets (if applicable), Material: 304 Stainless Steel 2. Share this notification with all users within your facility network of the Product to ensure they are also aware of this field action. 3. If you purchased this Product from a distributor, contact your distributor for further instructions and credit resolution. 4. Complete the attached Customer Response Form and return it to the BD contact noted on the form whether or not you have any of the Product so that BD may acknowledge your receipt of this notification per FDA requirements. 5. Indicate on the response form the quantity of Product identified at your facility and confirm that this Product inventory was disposed of. 6. Please contact your BD representative if you require assistance with this process or you may also contact the number below for further assistance."
Quantity in commerce: 895 units
Distribution: US and Australia, Bahrain, Canada, Denmark, Hong Kong, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Saudi Arabia, Singapore, South Africa, Sweden, Thailand, UK, United Arab Emirates
Product codes and lots: UDI/DI (01) 10885403019500, ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0216-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0204-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0205-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0206-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0207-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0208-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0209-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0210-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0211-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0212-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0213-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0214-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0215-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0216-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0217-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0218-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11
Z-0219-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-11

Product code KCT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)