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Recall Observatory FDA recall evidence

Device product

Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

Z-0242-2023

September 01, 2022

Class II

Product summary

Firm
Texas Medical Technology Inc.
Event
Event 90833
Status
Ongoing
Classification
Class II
Quantity
100,000
Official record key
device-enforcement:Z-0242-2023

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide distribution in the state of FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.