Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality control during production. Affected lot numbers include V18031235 through V19028470. Consumers should contact the company for details.
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Degania Medical Devices is recalling temperature sensing silicone catheters that may have been made with faulty thermistor sensors. This could lead to inaccurate temperature readings during urinary drainage, potentially causing health risks if not properly monitored.
The catheters were produced using thermistor sensors that may not have been properly inspected during manufacturing. This could result in inaccurate temperature readings when draining the urinary bladder, which might affect patient monitoring.
Patients using the recalled temperature sensing catheters for urinary drainage are affected. Those with medical conditions requiring precise temperature monitoring may be at higher risk.
Check for lot numbers V18031235, V18050229, V18050230, V18050231, V18050232, V18050233, V19027860, or V19028470 on the packaging. The product is a 3 lumen silicone catheter with a temperature sensor.
Look for lot numbers V18031235 through V19028470 on the catheter packaging.
The catheters may have thermistor sensors that were not properly inspected during production, which could lead to inaccurate temperature readings during urinary drainage.
Check the lot numbers on the packaging: V18031235, V18050229, V18050230, V18050231, V18050232, V18050233, V19027860, or V19028470.
The recall does not specify a remedy, so contact Degania Medical Devices directly for instructions.
We’ve drafted a message you can send Degania Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-1787-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1787-2020 from Degania Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
