ReCor Medical Inc. has issued an active recall for 24 Paradise ultrasound renal denervation catheters distributed nationwide in nine states. The devices were nonconforming and were supposed to be scrapped and not for human use. Healthcare providers and patients should stop using the devices immediately and await manufacturer recall instructions.
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ReCor Medical Inc. or your healthcare provider for instructions. Notification method: Letter
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Model/Catalog Number PRDS-068-02. UDI-DI 00810008950043. Lot Number M4862. Quantity 24. Sold nationwide in CA, CO, FL, KS, MO, NC, OH, TX, and VA.
The recall concerns a nonconforming product that was distributed and not approved for human use. It requires immediate action to prevent potential harm to patients.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow the recall instructions provided by the manufacturer. 3. Contact ReCor Medical Inc. or your healthcare provider for instructions. 4. Notification by letter is the official method.
Phone: Unknown. Website: Unknown. Hours: Unknown.
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