Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
FDA device recall Z-0242-2023 · posted 2022-11-16 · Open, Classified
Recall details
- Recalling firm
- Texas Medical Technology Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FYA
- Quantity affected
- 100,000
- Distribution
- US Nationwide distribution in the state of FL.
- Date initiated
- 2022-09-01
- Date posted
- 2022-11-16
- Location
- Sugar Land, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE SURGICAL GOWNS (K120192) | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 2012-10-16 |