FDAFDA · Food and drugs·Recall number Z-1779-2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201100880MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Published April 29, 2020 · Recall initiated: March 17, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Degania Medical Devices Pvt. Ltd.
- Distributor
- Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico.
- Lot
- Lot Numbers: S18013318 S18010936 S19006220 S19006221 S19006222 S19006349
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- India
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