Dover Foley Catheters Recalled for Temperature Sensor Inaccuracy
FDA is recalling 480 Dover Foley catheters with temperature sensors that failed to meet accuracy standards, posing a risk of incorrect patient 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, and the hazard involves a risk of harm (incorrect diagnosis and insufficient treatment) without reported injuries or illnesses, fitting 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) is recalling 480 units of Dover 100% Silicone Silver-Hydrogel Coated Foley Catheters with Temperature Sensors (16FR, Product Code 50516ICT, Lot Number 1909500464). The recall was initiated by the manufacturer, Covidien Llc, due to a defect in the temperature sensing mechanism.
The recalled 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 patients.
These prescription-only devices were distributed nationwide in the United States. They are used for the drainage of the urinary bladder and simultaneous monitoring of temperature. Healthcare facilities and consumers should stop using these specific units and contact the manufacturer or FDA for further instructions.
The recalled product
- Product
- Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only.
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Foley Catheter
- Affected units
- 480
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: 1909500464
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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