Degania Medical recalls temperature sensing silicone catheters with potential quality control issues. Affected lots include S18013318, S18010936, S19006220, S19006221, S19006222, S19006349. No remedy specified in recall notice.
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 been made with faulty thermistor sensors due to inadequate quality checks. This could lead to inaccurate temperature readings during urinary drainage, potentially causing complications if the catheter malfunctions.
The catheters may have thermistor sensors that don't work properly because of poor quality control during manufacturing. This could cause inaccurate temperature readings during bladder drainage, which might lead to complications if the catheter malfunctions.
Patients using the recalled catheters for urinary drainage. Those with medical conditions requiring precise temperature monitoring may be at slightly higher risk.
Check for lot numbers: S18013318, S18010936, S19006220, S19006221, S19006222, or S19006349 on the packaging. The product is a 3 lumen silicone catheter with a temperature sensor for urinary drainage.
Look for lot numbers S18013318, S18010936, S19006220, S19006221, S19006222, or S19006349 on the packaging.
The recall is due to inadequate quality control during manufacturing, which may result in faulty thermistor sensors affecting temperature readings.
The recall notice does not specify a remedy. Check the lot number to see if your product is affected.
The recall indicates a potential for inaccurate temperature readings, but no specific risk of serious injury is mentioned.
We’ve drafted a message you can send Degania Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1779-2020 — Degania Medical Degania Medical Hello, I own a Degania Medical that is covered by recall Z-1779-2020 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.
