Degania Silicone recalls temperature sensing catheters that may show lower body temperature readings due to defective sensors. Affected units have specific catalogue numbers and were sold for surgical use. Consumers should contact the manufacturer for details.
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Degania Silicone is recalling temperature sensing catheters that may show lower body temperature readings than actual patient temperatures due to defective sensors. This could lead to inaccurate temperature monitoring during surgery or post-surgical care, potentially affecting patient safety.
The catheters contain defective temperature sensors that may display lower body temperature readings than the actual patient temperature. This could lead to incorrect temperature monitoring during critical medical procedures, potentially causing complications if the patient's true temperature is not accurately assessed.
Medical professionals using the catheters for surgical procedures or post-surgical care are most at risk. Patients undergoing surgery or recovery with this device may also be affected.
Check for the catalogue number 102201101463NU on the catheter packaging or label. The product is a sterile, single-use silicone Foley catheter with a thermistor embedded in the third lumen, intended for surgical temperature monitoring.
Reach out to Degania Silicone directly for specific instructions on how to verify if your catheter is affected and what to do next.
The catheters are suspected to contain defective sensors that may show lower body temperature than the actual patient temperature, which could lead to inaccurate monitoring during surgery or post-surgical care.
Check for the catalogue number 102201101463NU on the catheter packaging or label. The product is a sterile, single-use silicone Foley catheter with a thermistor embedded in the third lumen.
Contact Degania Silicone directly for specific instructions on how to verify if your catheter is affected and what to do next.
We’ve drafted a message you can send Degania Silicone to request your refund or repair — edit it as you like.
Subject: Recall Z-2784-2018 — Degania Silicone Degania Silicone Hello, I own a Degania Silicone that is covered by recall Z-2784-2018 from Degania Silicone. 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.
