Recall Z-0129-2022— Stradis Medical, LLC dba Stradis Healthcare

Name: FDA recall Z-0129-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-10

Class II · Ongoing

Class II FDA medical device recall by Stradis Medical, LLC dba Stradis Healthcare, initiated 2021-09-10. It names one FDA 510(k) clearance: K073182. Product: Endometrial Biopsy Kit. Reason: Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards..

Recalling firm: Stradis Medical, LLC dba Stradis Healthcare
Classification: Class II
Status: Ongoing
Initiated: 2021-09-10
Firm location: Peachtree Corners, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K073182 — GYN DISPOSABLES TENACULUM 356TGyn-Disposables, Inc.·cleared 2007-11-28

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

Endometrial Biopsy Kit

Reason for recall

Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.

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