Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality checks on thermistor sensors. Affected lots include V18024145 through V19027865. 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 that may have faulty thermistor sensors due to inadequate quality control during production. 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 have been properly inspected for quality. This could result in inaccurate temperature readings during urinary drainage, which might lead to improper medical monitoring if the patient's temperature is not correctly tracked.
Patients using the recalled temperature sensing catheters for urinary drainage are affected. Healthcare providers who use these catheters in medical settings may also be impacted.
Check the product label for lot numbers: V18024145, V18024144, V18027064, V18026042, V18026043, V18026045, V18029205, V18029206, V19037913, V18049310, V19007111, V19007110, V19008666, V19008664, V19009594, V19013277, V19027814, V19027863, V19027865. The product is a 3 lumen silicone catheter with a temperature sensor.
Look for lot numbers on the catheter label: V18024145 through V19027865.
The catheters may have faulty thermistor sensors due to inadequate quality control during production, which could lead to inaccurate temperature readings during urinary drainage.
Check the product label for lot numbers: V18024145, V18024144, V18027064, V18026042, V18026043, V18026045, V18029205, V18029206, V19037913, V18049310, V19007111, V19007110, V19008666, V19008664, V19009594, V19013277, V19027814, V19027863, V19027865.
The recall does not specify a remedy, so contact Degania Medical Devices directly 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-1788-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1788-2020 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.
