The Recall Desk
HighFDA (Devices)·Z-1789-2020·Announced 2020-04-29

Degania Temperature Sensing Foley Catheters Recalled for Sensor Inspection Failures

Degania Medical Devices is recalling specific lots of temperature sensing Foley catheters due to inadequate inspection of thermistor sensors.

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. Per the rubric, this falls under 'High' severity as it involves a risk-of-harm product where specific injury reports are not detailed in the source text, but the defect involves a functional sensor in a medical device.

Plain-English summary

Degania Medical Devices Pvt. Ltd. is recalling 1,578 units of Temperature Sensing 100% Silicone Foley Catheters, Part Number 102203101863DO. The affected lots are V19008709 and V19016709. These medical devices are 3-lumen silicone catheters designed to measure temperature while draining the urinary bladder.

The recall was initiated because inadequate incoming inspection practices were utilized on the thermistor sensors used in the production of these specific lots. The FDA has classified this as a Class II recall.

The affected products were distributed worldwide, including nationwide distribution in the United States (specifically noting the state of Illinois) and in Mexico. Users of these devices should stop using the affected lots and contact the manufacturer for further instructions.

The recalled product

Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101863DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Manufacturer
Degania Medical Devices Pvt. Ltd.
Category
Medical Device — Urological Catheters
Hazard
Affected units
1,578

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: V19008709 V19016709

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 11 recalled by Degania Medical Devices Pvt. Ltd. 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 →

Related recalls

Same manufacturer · Degania Medical Devices Pvt. Ltd.

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Same hazard · sensor defect

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