Agency classClass IIOur severity:High FDA (Devices)·Z-1993-2020·Announced 2020-05-20

Recall of Dover Foley Catheters Due to Temperature Sensor Inaccuracy

FDA is recalling 120 units of Dover Foley catheters because temperature sensors failed to meet calibration standards, potentially leading to incorrect diagnoses.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 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 120 units of Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Trays, Product Code P4P18XTS. These sterile medical devices are used for the drainage of the urinary bladder and simultaneous monitoring of body temperature. The recall involves Lot Number 1919708264, 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. The FDA notes that the failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment.

This recall is classified as Class II by the FDA. Healthcare providers and facilities that have purchased or received these specific units should stop using them and contact the recalling firm, Covidien LLC, for further instructions on return or replacement.

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 Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous…
Manufacturer: Covidien Llc
Category: Medical Device — Foley Catheters
Hazard: mis-labeling
incorrect-diagnosis
Affected units: 120

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: 1919708264

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.

See all 11 products in this recall →

Same manufacturer · Covidien Llc

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