Dover Silicone Foley Catheter Recalled for Temperature Sensor Inaccuracy
Covidien is recalling Dover 100% Silicone Foley trays because the temperature sensors failed to meet calibration standards, potentially leading to incorrect patient 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 sensor inaccuracy, 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 has issued a Class II recall for the Dover 100% Silicone Premium Urine Meter Foley Tray, manufactured by Covidien LLC. The affected product is a sterile, prescription-only medical device used for urinary bladder drainage and simultaneous temperature monitoring. The recall involves 3,470 units distributed nationwide in the United States.
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 source text, failure to correctly measure these temperatures could lead to an incorrect diagnosis and insufficient treatment for the patient.
Healthcare providers and facilities should stop using the affected lots immediately. The specific lot numbers identified in the recall are 1909308464 and 1933000164. The product code is P4P14TSD. Users should contact the manufacturer or follow FDA guidance for the proper disposition of these devices.
The recalled product
- Product
- Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P14TSD - Product Usage: for Drainage of the Ur
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Catheters
- Affected units
- 3,470
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: 1909308464
- 1933000164
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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