FDA Recalls Dover Foley Catheters Due to Temperature Sensor Failures
FDA is recalling Dover Foley catheters because their temperature sensors failed to meet calibration standards, which could lead 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 incorrect diagnosis and insufficient treatment due to sensor failure, which fits 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 46,828 units of Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Trays. The recall is being conducted by the manufacturer, Covidien LLC. These medical devices are used for the drainage of the urinary bladder and simultaneous monitoring of temperature, and are intended for prescription use only.
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 the failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment.
The affected products were distributed nationwide in the United States. The specific lot numbers involved in this recall are 1828206564, 1828813264, 1829618264, 1829618364, 1831001964, 1906506564, 1907134164, 1909308864, 1919705064, 1921106664, 2000723764, 2003520164, and 2005617664. Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 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: P4P16XTSD - Product Usage:
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Foley Catheter
- 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 (7)
- Lot Numbers: 1828206564
- 1828813264 1829618264
- 1829618364 1831001964
- 1906506564 1907134164
- 1909308864 1919705064
- 1921106664 2000723764
- 2003520164 2005617664
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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