Degania Medical Devices recalls temperature sensing silicone catheters due to inadequate quality control during production. Affected lot numbers include V18022049 to V18052880 and V19000868. 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 with specific lot numbers because of inadequate quality control during production. This could lead to inaccurate temperature readings, which might affect medical treatment decisions.
The catheters were produced with thermistor sensors that may not have been properly inspected during manufacturing. This could result in inaccurate temperature readings when draining the urinary bladder, potentially affecting medical treatment decisions.
Patients using the recalled catheters for urinary drainage are affected. Healthcare providers who use these catheters in medical settings may also be impacted.
Check the lot numbers on the catheter packaging: V18022049, V18022050, V18026085, V18026084, V18034279, V18052058, V18052059, V18052880, and V19000868. The product is a 3 lumen silicone catheter with a temperature sensor.
Look for the specific lot numbers listed in the recall: V18022049, V18022050, V18026085, V18026084, V18034279, V18052058, V18052059, V18052880, and V19000868.
The catheters were produced with thermistor sensors that may not have been properly inspected during manufacturing, potentially leading to inaccurate temperature readings.
Check the lot numbers on the catheter packaging: V18022049, V18022050, V18026085, V18026084, V18034279, V18052058, V18052059, V18052880, and V19000868.
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-1784-2020 — Degania Medical Devices Degania Medical Devices Hello, I own a Degania Medical Devices that is covered by recall Z-1784-2020 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.