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U.S. Department of Health and Human Services

Class 2 Device Recall CareFusion V.Meuller

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  Class 2 Device Recall CareFusion V.Meuller see related information
Date Initiated by Firm September 26, 2022
Date Posted November 11, 2022
Recall Status1 Open3, Classified
Recall Number Z-0208-2023
Recall Event ID 90958
Product Classification Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
Product CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4" (10CM) DEEP STERRAD COMPATIBLE, REF CD2-4ST
Code Information UDI/DI (01) 10885403019111, ALL LOTS
Recalling Firm/
Manufacturer		 Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845
For Additional Information Contact
847-362-8070
Manufacturer Reason
for Recall		 Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
FDA Determined
Cause 2		 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 319 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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