Degania Medical Devices recalls temperature sensing silicone catheters with potential quality control issues affecting safety. Affected lot numbers V19012401 and V19012403.
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 quality control issues during production. This could affect safety if the catheter fails to properly measure temperature during use.
The recall states inadequate incoming inspection practices were used on thermistor sensors during production. This could lead to faulty temperature measurements during urinary drainage, potentially causing unsafe conditions.
Patients using the recalled catheters for urinary drainage are most at risk. Healthcare providers who use these catheters in medical settings may also be affected.
Check for lot numbers V19012401 or V19012403 on the catheter packaging. The product is a 3 lumen silicone catheter with a temperature sensor for urinary drainage.
Look for lot numbers V19012401 or V19012403 on the catheter packaging.
Temperature Sensing 100% Silicone Foley Catheter with lot numbers V19012401 or V19012403.
Inadequate incoming inspection practices were used on thermistor sensors during production, which could affect temperature measurement safety.
Check the lot numbers on the packaging. If it matches V19012401 or V19012403, contact the manufacturer 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-1786-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1786-2020 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.
