Dover Silicone Foley Catheter Recall for Temperature Sensor Inaccuracy
FDA is recalling Dover silicone Foley catheters with temperature sensors that failed to meet calibration 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. 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 8,162 units of the Dover 100% Silicone Premium Urine Meter Tray. This medical device includes a 16 Fr Foley catheter pre-connected to a drainage bag with a temperature sensor. The product is intended for the drainage of the urinary bladder and simultaneous monitoring of body temperature. The recall is classified as Class II by the FDA.
The recall was initiated because the temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2°C. The source text states that failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment. The affected lot numbers are 1909308664, 1909320964, and 1933802964. The product was distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected devices immediately. Users should contact the recalling firm, Covidien LLC, for instructions on how to return or dispose of the product. This recall is for prescription use only.
The recalled product
- Product
- Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P16TS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature
- Manufacturer
- Covidien Llc
- Category
- Medical Device — Foley Catheter
- Affected units
- 8,162
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: 1909308664
- 1909320964 1933802964
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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