Foundation Kit
Reported: October 27, 2021 Initiated: September 10, 2021 #Z-0130-2022
Product Description
Foundation Kit
Reason for Recall
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Details
- Recalling Firm
- Stradis Medical, LLC dba Stradis Healthcare
- Units Affected
- 790 kits
- 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.
- Location
- Peachtree Corners, GA
Frequently Asked Questions
What product was recalled? ▼
Foundation Kit. Recalled by Stradis Medical, LLC dba Stradis Healthcare. Units affected: 790 kits.
Why was this product recalled? ▼
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 27, 2021. Severity: Moderate. Recall number: Z-0130-2022.
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