Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Summary
The FDA issued a Class II for Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GW by Texas Medical Technology Inc.. 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 lev.
Details
Source
Device Recall
External ID
Z-0242-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
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
Lot/Code Info: 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
Quantity Affected: 100,000
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.
Distribution
US Nationwide distribution in the state of FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-01
Company
Sugar Land, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Texas Medical Technology Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Texas Medical Technology Inc. have FDA actions?
This is the only FDA action we have on record for Texas Medical Technology Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0242-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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