CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5" (12.7CM) DEEP STERRAD COMPATIBLE, REF CD1-5

FDA device recall Z-0206-2023 · posted 2022-11-11 · Open, Classified

Recall details

Recalling firm

Carefusion 2200 Inc

Reason for recall

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

Action taken

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."

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KCT

Quantity affected

1132 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

Date initiated

2022-09-26

Date posted

2022-11-11

Location

Vernon Hills, IL