—#211013

Product

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

FDA product code: FYC — Gown, Isolation, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K160339
Affected lot / code info: 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

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 GMB-FieldCorrectiveAction@cardinalhealth.com, 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: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US Nationwide. Canada, UAE

Timeline

Recall initiated: 2024-11-01
Posted by FDA: 2024-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.