Recall Z-0674-2025 ยท FYC Gown, Isolation, Surgical
Cardinal Health 200, LLC
Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL
| Date | Dec 11, 2024 (initiated Nov 1, 2024) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 940,203 total units |
| Distribution | US Nationwide. Canada, UAE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160339 | Cardinal Health Isolation Gown Cardinal Health200, LLC, Jul 28, 2016 |