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Convertor Isolation Gown, AAMI Level 3 protection, Product… recallZ-0674-2025 · Cardinal Health 200, LLC · initiated Nov 1, 2024

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 Cardinal Health 200, LLC 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

Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT MEDICAL DEVICE PRODUCT RECALL notification letter dated 11/1/24 was sent to customer. Actions Required: 1. REVIEW your inventory for the affected product codes. Location of product code and is shown on the label below (Attachment 1). 2. COMMUNICATE with all personnel that utilize the above listed Cardinal Health AAMI Level 3 Isolation Gowns. 3. SEGREGATE and quarantine all affected product upon review of your inventory. Affected product should not be used. Utilize return directions below to return product. 4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected products. 5. DISTRIBUTORS please notify any customers to whom you may have distributed/ forwarded affected product to or will send the product on to about this medical device product recall and share a copy of this notice. 6. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email directly to [email protected], whether you have affected product or not. Return of Product and Available Assistance: CONTACT the appropriate Customer Service group with questions relating to credit, replacement, and suitable alternative products. Monday Friday between 8:00am - 5pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

Recall details

Recall number
Z-0674-2025
Status
Open, Classified
Initiated by the company
Nov 1, 2024
Posted by the FDA
Dec 11, 2024
Recalling firm
Cardinal Health 200, LLC
Quantity
940,203 total units
Product code
FYC
FDA submissions
K160339
Distribution
US Nationwide. Canada, UAE

Product description

Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL

Code information (models, lots, serial numbers)

All Lots. AT6100 UDI-DI: CS (01) 50192253048252 EA (01) 20192253048251; AT6100-XL UDI-DI: CS (01) 50192253048269 EA (01) 20192253048268; AT6200 UDI-DI: CS (01) 50192253048276 EA (01) 20192253048275; AT6200-XL UDI-DI: CS (01) 50192253048283 EA (01) 20192253048282

Devices named in this recall

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

Other products in the same recall event

The FDA groups related products into one recall event (event 95727).

Sources and updates

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