Recall Z-0242-2023— Texas Medical Technology Inc.

Name: FDA recall Z-0242-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-01

Class II · Ongoing

Class II FDA medical device recall by Texas Medical Technology Inc., initiated 2022-09-01. It names one FDA 510(k) clearance: K120192. Product: Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B. 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 level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric..

Recalling firm: Texas Medical Technology Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-01
Firm location: Sugar Land, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120192 — DISPOSABLE SURGICAL GOWNSWeihai Hongyu Nonwoven Fabric Products Co., Ltd.·cleared 2012-10-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.