Sugar Land, TX, United States
Texas Medical Technology Inc. recalls
1 recall recorded since 2018, most recently on 1 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 September 2022
- 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.
- Distribution
- US Nationwide distribution in the state of FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0242-2023
- Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.