FDA Recalls Dover Foley Catheters Due to Temperature Sensor Inaccuracy
The FDA is recalling specific lots of Dover Foley catheters because their temperature sensors may not measure accurately. This could lead to incorrect patient diagnoses.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is assigned a score of 4 (Severe), particularly given the potential for incorrect diagnosis and insufficient treatment.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling 46,828 units of Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Trays. The affected product is a sterile, prescription-only medical device used for urinary bladder drainage and simultaneous temperature monitoring. The recall covers units with Product Code P4P16XTSD and Lot Numbers 1828205964 and 1911414164, which were 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. The FDA notes that failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and facilities should stop using the affected lots immediately. Consumers who have purchased this prescription device should contact their healthcare provider or the manufacturer, Covidien LLC, for further instructions on how to proceed.
The recalled product
- Product
- Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16
- Manufacturer
- Covidien Llc
- Affected units
- 46,828
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: 1828205964
- 1911414164
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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