Iantrek recalled 1,262 units of the Cyclopen Microinterventional Cyclodialysis System on September 6, 2025. The recall stems from a risk of compromised sterile packaging that could affect patient safety. Health care providers and patients must stop using the device immediately and follow manufacturer instructions.
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
The recalled product is the Cyclopen Microinterventional Cyclodialysis System, Model Number CP-300. It was distributed nationwide in various states, including California and Texas. The product is classified as a Class II medical device.
The recall involves a potential risk due to compromised integrity of the sterile packaging. This issue may lead to infections or other complications during surgical procedures.
There are no reported incidents or injuries related to this recall as of the report date. The FDA has classified the hazard level as high.
Patients and healthcare providers should stop using the device immediately. Contact Iantrek Inc. or your healthcare provider for further instructions.
For more information, contact Iantrek Inc. via email or visit their official website. More details are also available at the FDA recall page.
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