FDAFDA · Food and drugs·Recall number Z-2761-2018
Temperature Sensor Catheter 16FR, Catalogue Number 102201101663BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
Published September 26, 2018 · Recall initiated: June 21, 2018
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
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Degania Silicone, Ltd.
- Distributor
- Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
- Lot
- V17018057, V17022043, V17023777, V17018058, V17012115, V17002305, V17002306, V17002308
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Israel
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