Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality control during production, potentially leading to inaccurate temperature readings.
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 inaccurate temperature readings due to production quality control issues. This could lead to improper medical decisions if the catheter's temperature measurement is incorrect.
The catheters were produced with thermistor sensors that may not function correctly due to inadequate incoming inspection practices. This could result in inaccurate temperature measurements during urinary drainage, potentially leading to incorrect medical decisions.
Patients using the recalled catheters for urinary drainage may be affected. Healthcare providers who use these catheters for medical monitoring are at risk of potential inaccuracies in temperature readings.
Check for the product name 'Temperature Sensing 100% Silicone Foley Catheter' with part number 102203101863DO. The lot numbers V19008709 and V19016709 are associated with this recall.
Identify the part number and lot numbers to confirm if your catheter is affected.
The recall is due to inadequate incoming inspection practices during production, which may result in inaccurate temperature readings.
Check the part number and lot numbers to determine if your catheter is affected. If it is, contact Degania Medical Devices for further instructions.
The recall indicates a potential for inaccurate temperature readings, but there is no mention of serious injury risk in the official notice.
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-1789-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1789-2020 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.
