IUD Insertion Pack recall
IUD Insertion Pack
Why was IUD Insertion Pack 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: 618-034
- Product
- IUD Insertion Pack
- Recalling firm
- Stradis Medical, LLC dba Stradis Healthcare
- Quantity
- 20 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)