Z-0674-2025Class II

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

Name: Z-0674-2025 Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Creator: Cardinal Health 200, LLC
Published: 2024-11-01
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2024-11-01 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL on 2024-11-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0674-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-11-01
Posted: 2024-12-11
Recalling firm: Medtronic, Inc.
Product: Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Product code: FYC Gown, Isolation, Surgical
Reason for recall: 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 tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 940,203 total units
Distribution: US Nationwide. Canada, UAE
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-11
Z-0675-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-18	2024-12-11

Product code FYC

K160339Class IICardinal Health Isolation GownCardinal Health200, LLC / cleared 2016-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)