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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Surgical Level 3 Gown

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  Class 2 Device Recall Disposable Surgical Level 3 Gown see related information
Date Initiated by Firm September 01, 2022
Date Posted November 16, 2022
Recall Status1 Open3, Classified
Recall Number Z-0242-2023
Recall Event ID 90833
510(K)Number K120192  
Product Classification Gown, surgical - Product Code FYA
Product Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
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
Recalling Firm/
Manufacturer		 Texas Medical Technology Inc.
1111 Gillingham Ln
Sugar Land TX 77478-2865
For Additional Information Contact
346-397-0261
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 9/1/22, a recall notice was sent to a distributor who was asked to forward the recall notice to their customers. Customers are asked to return the gowns to the distributor and to complete a self-address questionnaire to the recalling firm. The following contact information was provided: 346-250-2655, Monday through Friday 8 AM to 5 PM Central Time, sales@texasmedicaltechnology.com On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns.
Quantity in Commerce 100,000
Distribution US Nationwide distribution in the state of FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FYA and Original Applicant = WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
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