Iantrek recalled 198 C-Rex UNO Microinterventional Goniotomy Instruments, CRX-120 models, distributed nationwide to healthcare facilities. The recall cites potential compromised integrity of the sterile packaging. Healthcare providers and patients should stop using the device immediately and follow recall instructions via the manufacturer.
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 C-Rex UNO Microinterventional Goniotomy Instrument CRX-120 is a sterile single-use disposable surgical instrument used in ophthalmic procedures for ab interno goniotomy and inner wall trabeculotomy.
If the sterile packaging is compromised, sterility cannot be guaranteed, potentially increasing the risk of infection during surgery.
This recall is not described as part of a broader industry pattern in the provided information.
The issue could impact patient safety during eye surgery and may require rapid Instrument replacement to avoid infection risk.
UDI codes on packaging and device labeling; Lot numbers and Exp date printed on the packaging.
Recall resolution timelines are determined by the manufacturer; typical processes may take weeks to months.
Save all recall communications, photos of packaging, lot numbers, and dates; document device usage and patient consent in case of later review.
Model numbers: CRX-120. UDI: +B962CRX1200/$$7351729/16D20250501/14D20260501/Q1$ UDI: +B962CRX1200/$$7351759/16D20250501/14D20260501/Q1% Lot numbers: 351729 and 351759 Exp date: 05/2026 Quantity recalled: 198 units Sold/distributed: US nationwide to healthcare facilities (states listed in recall) Distribution: 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 status: Active Remedy: Stop use and follow manufacturer recall instructions Remedy contact: Iantrek Inc. recall notice via email
No injuries or incidents have been reported.
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