Z-2766-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- June 21, 2018
- Termination Date
- October 25, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 92150
Product Description
Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number 102201101680TY 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
Code Information
S17002091, S17002440, S17001607, S17002441, S17002558, S17002559, S17002561, S17002562, S17002563, S17002681, S17003391, S17004379, S17002560, S17002682, S17003456, S17003219, S17003301, S17003302, S17004772, S17004376, S17004377, S17004378, S17005117, S17005029, S17005281, S17005983, S17006720, S17004509, S17004510, S17004511, S17004771, S17004902, S17005028, S17005030, S17005529, S17005984, S17005985, S17004380, S17005979, S17006723, S17005980, S17005981, S17005982, S17005986, S17006718, S17006719, S17006721, S17006722, S17006724, S17006725, S17007360, S17007459, S17007622, S17002986, S17006363, S17007623, S17002987, S17007806, S17008017, S17002090