Recall Z-0242-2023 ยท FYA Gown, Surgical
Texas Medical Technology Inc.
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
| Date | Nov 16, 2022 (initiated Sep 1, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/1/22, a recall notice was sent to a distributor who was asked to forward the recall notice to their customers. Customers are asked to return the gowns to the distributor and to complete a self-address questionnaire to the recalling firm. The following contact information was provided: 346-250-2655, Monday through Friday 8 AM to 5 PM Central Time, sales@texasmedicaltechnology.com On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns. |
| Quantity | 100,000 |
| Distribution | US Nationwide distribution in the state of FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120192 | DISPOSABLE SURGICAL GOWNS Weihai Hongyu Nonwoven Fabric Products Co., Ltd., Oct 16, 2012 |