Product Safety Recalls

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Texas Medical Technology Inc. Recall 90833

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

Texas Medical Technology Inc. Recall 90833 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0242-2023
Event ID90833
Event DescriptionDisposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Product TypeDevices
DistributionUS Nationwide distribution in the state of FL.
Quantity100,000
Recall ReasonSurgical 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.
Device Classification20221123
Device Code InfoProduct 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
Center Classification Date20221116
Recall Initiation Date20220901
Recalling FirmTexas Medical Technology Inc.
Initial Notification Letter
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