Dover Silicone Foley Catheters Recalled for Temperature Measurement Failures
FDA is recalling Dover 100% Silicone Foley Catheters because they failed to meet temperature sensing tolerances, potentially leading to incorrect diagnoses.
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) due to device malfunction, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Dover 100% Silicone Foley Catheters with Temperature 16FR 5CC2W, manufactured by Covidien LLC. The affected products are used for the drainage of the urinary bladder and simultaneous monitoring of temperature. The recall involves 3,012 units distributed nationwide in the United States. The specific lot numbers affected are 1908700664 and 1918351164.
The recall was initiated because the temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2°C. This defect means the devices may not correctly measure patient body temperatures.
According to the FDA, failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Catheters
- Affected units
- 3,012
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 (2)
- Lot Numbers: 1908700664
- 1918351164
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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