| Class 2 Device Recall CareFusion V.Meuller | |
Date Initiated by Firm | September 26, 2022 |
Date Posted | November 11, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0214-2023 |
Recall Event ID |
90958 |
Product Classification |
Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
|
Product | CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD3-6ST |
Code Information |
UDI/DI (01) 10885403019395, 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 | 318 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 |
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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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