Iantrek recalled 1,262 CycloPen CP-300 Cyclodialysis System units distributed nationwide to medical facilities. The recall stems from a potential compromise to sterile packaging integrity. Hospitals and clinics should stop using the device immediately and follow Iantrek’s recall instructions via email.
Potential for compromised integrity of the sterile packaging.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Iantrek Inc. or your healthcare provider for instructions. Notification method: E-Mail
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The CycloPen Microinterventional Cyclodialysis System CP-300 is a manual surgical instrument used in eye surgery to create or modify a cyclodialysis and deliver materials to reinforce the surgical site.
A compromised sterile barrier may render the device non-sterile. Using a non-sterile instrument in intraocular surgery can increase the risk of infection and complications.
This recall is not described as part of a broader industry pattern in the provided notice.
Facilities may need to replace affected devices and review sterile-packaging controls. There is potential patient risk if non-sterile devices are used in procedures.
Recall notices and device identifiers can be found on the FDA enforcement page linked in the recall record and the manufacturer communications
Hospitals and clinics should expect follow-up guidance from Iantrek; replacement or remediation timelines are not specified
Document the recall notice, model CP-300, UDIs, lot numbers, expiration dates, date of receipt, and all correspondence with Iantrek
Brand: Iantrek. Product: CycloPen Microinterventional Cyclodialysis System CP-300. Model numbers: CP-300. UDI: +B962CP3000/$$7351645/16D20250201/14D20260201/Q1_, +B962CP3000/$$7351726/16D20250501/14D20260501/Q11, +B962CP3000/$$7351795/16D20250601/14D20260601/Q19. Lot numbers: 351645, 351726, 351795. Expiration dates: 02/2026, 05/2026, 06/2026. Quantity recalled: 1,262 units. Distribution: US nationwide in the states listed. Sold at: Unknown. Price: Unknown. Date sold: Unknown. Manufacturer country: Unknown.
No injuries or incidents have been reported.
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