Standard IUD Insertion Kit recall
Standard IUD Insertion Kit
Why was Standard IUD Insertion Kit recalled?
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: M20
- Product
- Standard IUD Insertion Kit
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 280 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.
- Recall date
- October 27, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)