Cyclopen Microinterventional Cyclodialysis System recall
Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is…
Why was Cyclopen Microinterventional Cyclodialysis System recalled?
Potential for compromised integrity of the sterile packaging.
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?
1. Model Number CP-300; UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_; Lot Number: 351645; Exp date 02/2026. 2. Model Number CP-300; UDI: +B962CP3000/$$7351726/16D20250501/14D20260501/Q11; Lot Number 351726; Exp date 05/2026. 3. Model Number CP-300; UDI: +B962CP3000/$$7351795/16D20250601/14D20260601/Q19; Lot Number 351795; Exp date 06/2026.
- Product
- Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is…
- Recalling firm
- Iantrek Inc.
- Quantity
- 1,262 units
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Recall date
- October 22, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)