Dover Foley Catheter Recalled for Temperature Sensor Calibration Failures
Covidien is recalling Dover Foley catheters with temperature sensors that failed to meet calibration tolerances, posing a risk of incorrect diagnosis.
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 incorrect diagnosis and insufficient treatment due to sensor failure, which fits 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 the Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor (18FR, Product Code: 50518ICT). The recall is being conducted by the manufacturer, Covidien LLC. The affected product is intended for the drainage of the urinary bladder and simultaneous monitoring of temperature, and is for prescription use only.
The recall was initiated because the temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2°C. The FDA notes that the failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment. The source text does not specify the number of units affected or the specific distribution dates, but notes US Nationwide distribution.
Healthcare providers and facilities should stop using the affected lot (1914135864) immediately. Patients who have used these catheters should contact their healthcare provider if they have concerns regarding their temperature readings or diagnosis. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- Manufacturer
- Covidien Llc
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 Numbers: 1914135864
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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