Texas Medical Technology Inc. Recall 90833
Description: Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Texas Medical Technology Inc. Recall 90833 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0242-2023 |
| Event ID | 90833 |
| Event Description | Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of FL. |
| Quantity | 100,000 |
| Recall Reason | Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric. |
| Device Classification | 20221123 |
| Device Code Info | Product Code/UDI-DI/Lots: GWS-03-L-B/00850022960338/1300001, 1300002, 1300003, 1300004; GWS-03-XL-B/00850022960345/1400001, 1400002, 1400003, 1400004; GWS-03-XXL-B/00850022960352/1500001, 1500002, 1500003, 1500004 |
| Center Classification Date | 20221116 |
| Recall Initiation Date | 20220901 |
| Recalling Firm | Texas Medical Technology Inc. |
| Initial Notification | Letter |
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