Degania Medical recalls temperature sensing silicone catheters due to inadequate quality checks on thermistor sensors. Affected lots include V18007422 through V19027235. 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 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 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 lead to complications if the temperature is not monitored correctly.
Patients using the recalled catheters for urinary drainage are most at risk, particularly those with medical conditions requiring precise temperature monitoring. Healthcare providers using these catheters in clinical settings may also be affected.
Check the product label for the part number 102201101663MD and lot numbers listed: V18007422 through V19027235. The catheter is a 3-lumen silicone type with a temperature sensor for urinary drainage.
Look for the part number 102201101663MD and lot numbers from the list provided in the recall notice.
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 the part number 102201101663MD and lot numbers from the list: V18007422 through V19027235.
The recall notice does not specify a remedy, so contact Degania Medical directly for further instructions.
We’ve drafted a message you can send Degania Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1783-2020 — Degania Medical Degania Medical Hello, I own a Degania Medical that is covered by recall Z-1783-2020 from Degania Medical. 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.
