Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
- Company
- Texas Medical Technology Inc.
- Recall Initiated
- September 1, 2022
- Posted
- November 16, 2022
- Recall Number
- Z-0242-2023
- Quantity
- 100,000
- Firm Location
- Sugar Land, TX
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.
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
Root Cause
Nonconforming Material/Component
Action Taken
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.