FDA recall Z-0127-2022

Stradis Medical, LLC dba Stradis Healthcare · Class II · device

Product

IUD Insertion Pack

Reason for recall

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

Distribution

Distributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK, WA, NY, NV, MO, MD, IN, TX, CO, RI, NC, KY, MT, VI, GA, KS, MI, AK, ID, SD, UT and internationally to Canada.

Key facts

Status: Ongoing
Initiation date: 2021-09-10
Report date: 2021-10-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Peachtree Corners, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2022