Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
FDA recalls 468 Dover Foley catheters with temperature sensors that failed accuracy tests. Incorrect readings could lead to misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (incorrect diagnosis and insufficient treatment) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 468 units of the Dover 100% Silicone Foley Catheter with Temperature Sensor (14FR 5CC2W, Product Code: 50514T). The recall was initiated by the manufacturer, Covidien LLC, due to a defect in the temperature sensing mechanism.
The affected catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2°C. This inaccuracy means the devices may not correctly measure patient body temperatures. The FDA notes that failure to correctly measure body temperature could lead to an incorrect diagnosis and insufficient treatment for the patient.
The recalled products were distributed nationwide in the United States. The specific lot number is 1910100464. These devices are intended for prescription use only for the drainage of the urinary bladder and simultaneous monitoring of temperature. Healthcare facilities and patients should stop using these specific units and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- Manufacturer
- Covidien Llc
- Affected units
- 468
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 1910100464
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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