Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality control during production. Affected lot numbers include V18022033 through V19025875. Consumers should contact the manufacturer 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 because quality control during production was insufficient. This could lead to inaccurate temperature readings during urinary drainage, potentially causing health risks if not properly monitored.
The catheters were produced with thermistor sensors that may not function correctly due to inadequate quality checks. This could result in inaccurate temperature readings during bladder drainage, which might affect patient monitoring if not properly managed.
Patients using the recalled temperature sensing catheters for urinary drainage. Those with medical conditions requiring precise temperature monitoring are at higher risk.
Check for lot numbers V18022033, V18025110, V18025111, V18029225, V18029226, V19024273, V19013327, V19025875, or V19016720, V19025874 on the packaging or label.
Look for lot numbers V18022033 through V19025874 on the catheter packaging or label.
Temperature Sensing 100% Silicone Foley Catheter with 3 lumens and a temperature sensor.
Lot numbers V18022033, V18025110, V18025111, V18029225, V18029226, V19024273, V19013327, V19025875, V19016720, and V19025874.
The recall record does not specify a remedy, so contact Degania Medical Devices directly for guidance.
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-1782-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1782-2020 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.
