Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy
FDA is recalling specific Dover Foley catheters because their 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, and the hazard involves a risk of harm (incorrect diagnosis and insufficient treatment) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for specific lots of Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Trays. The recalled product, manufactured by Covidien LLC, is a sterile medical device used for the drainage of the urinary bladder and simultaneous monitoring of body temperature. The recall is limited to Lot Number 1914133564, which was 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 accurately measure patient body temperatures. The FDA notes that failure to correctly measure these temperatures could lead to an incorrect diagnosis and insufficient treatment for the patient.
Healthcare providers and facilities that have received this specific lot of the Dover Foley catheter should stop using the product immediately. They should contact the recalling firm, Covidien LLC, for instructions on how to return or dispose of the affected units. Patients who have had this specific device used on them should consult their healthcare provider if they have concerns regarding their temperature readings or diagnosis.
The recalled product
- Product
- Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code: P4P18XTSD - Product Usage:
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Catheters
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: 1914133564
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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