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V. Mueller recallZ-0210-2023 · Carefusion 2200 Inc · initiated Sep 26, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Carefusion 2200 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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."

Recall details

Recall number
Z-0210-2023
Status
Open, Classified
Initiated by the company
Sep 26, 2022
Posted by the FDA
Nov 11, 2022
Recalling firm
Carefusion 2200 Inc
Quantity
265 units
Product code
KCT
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 description

CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 6" (15.2CM) DEEP STERRAD COMPATIBLE, REF CD2-6ST

Code information (models, lots, serial numbers)

UDI/DI (01) 10885403019173, ALL LOTS

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90958).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page