FDAFDA · Food and drugs·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
Published November 23, 2022 · Recall initiated: September 1, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Texas Medical Technology Inc.
- Distributor
- US Nationwide distribution in the state of FL.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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