Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Reported: November 23, 2022 Initiated: September 1, 2022 #Z-0242-2023
Product Description
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
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.
Details
- Recalling Firm
- Texas Medical Technology Inc.
- Units Affected
- 100,000
- Distribution
- US Nationwide distribution in the state of FL.
- Location
- Sugar Land, TX
Frequently Asked Questions
What product was recalled? ▼
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B. Recalled by Texas Medical Technology Inc.. Units affected: 100,000.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Moderate. Recall number: Z-0242-2023.
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