Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality checks during production. Affected lot S18012796 may have faulty thermistor sensors.
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 faulty thermistor sensors due to inadequate quality control during production. This could lead to inaccurate temperature readings during urinary drainage.
The catheter uses a thermistor sensor to measure temperature while draining the bladder. Inadequate quality control during production could result in faulty sensors that provide inaccurate temperature readings.
Patients using the recalled catheter lot S18012796 for urinary drainage. Healthcare providers who use this specific model may be at risk if they have the affected lot.
Check for the lot number S18012796 on the catheter packaging. The product is a 3 lumen silicone catheter with a temperature sensor for urinary drainage.
Look for the lot number S18012796 on the catheter packaging to confirm if it's affected.
The recall is due to potential inaccurate temperature readings from faulty sensors, but no injuries have been reported.
Check the lot number S18012796 on the catheter packaging. The product is a 3 lumen silicone catheter with a temperature sensor for urinary drainage.
The recall does not specify a remedy, so contact Degania Medical Devices for further 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-1781-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1781-2020 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.
