Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
FDA Recall Z-0242-2023 · Posted 2022-11-16
Advertisement
Recalling FirmTexas Medical Technology Inc.
Recall StatusOpen, Classified
Product CodeFYA
Date Initiated2022-09-01
Product Quantity100,000
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.
Firm 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, [email protected]
On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the state of FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement