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U.S. Department of Health and Human Services

Class 2 Device Recall Convertor Isolation Gown

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 Class 2 Device Recall Convertor Isolation Gownsee related information
Date Initiated by FirmNovember 01, 2024
Date PostedDecember 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0674-2025
Recall Event ID 95727
510(K)NumberK160339 
Product Classification Gown, isolation, surgical - Product Code FYC
ProductConvertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
Code Information 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
FEI Number 3001236905
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn 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.
Quantity in Commerce940,203 total units
DistributionUS Nationwide. Canada, UAE
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = FYC
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