Z-2765-2018 Class II Terminated
FDA device recall Z-2765-2018 was initiated by Degania Silicone, Ltd. on June 21, 2018 and is designated Class II. 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. The recall status is terminated (terminated October 25, 2024). Affected quantity: 89122.
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
- 89122
Product Description
Foley Catheter with temperature sensor 400TM 14FR, Catalogue Number 102201101480TY 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
S17001226, S17002082, S17002550, S17002784, S17002883, S17002884, S17005004, S17003784, S17003785, S17002982, S17002983, S17003916, S17003917, S17004351, S17005957, S17006689, S17007029, S17004746, S17004877, S17005956, S17004486, S17006334, S17005958, S17006206, S17006333, S17006687, S17006688, S17000191, S17000192, S17000231, S17000320, S17000345, S17006690, S17006926, S17007030, S17007032, S17007334, S17007433, S17007434, S17007588, S17008088, S17005116, S17007031, S17003446, S17007599, S17007780, S17000335, S17002083