—#196281

Product

CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8" (30.3X20.3CM) 4" (10.2CM) DEEP STERRAD COMPATIBLE, REF CD0-4ST

FDA product code: KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: UDI/DI (01) 10885403018930, ALL LOTS

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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."

Recalling firm

Firm: Carefusion 2200 Inc 75 N Fairway Dr Vernon Hills IL 60061-1845

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2022-09-26
Posted by FDA: 2022-11-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196281. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.