[pending] Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The
Pending LLM rewrite. Source: FDA_DEVICE Z-0134-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential for compromised integrity of the sterile packaging.
The recalled product
- Product
- Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300. Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-interno construction or modification of a cyclodialysis, followed by delivery of
- Manufacturer
- Iantrek Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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.
Distribution
Distributed nationwide across the United States.
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