FDA recall Z-2776-2018

Degania Silicone, Ltd. · Class II · device

Product

Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD 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

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

Key facts

Status
Terminated
Initiation date
2018-06-21
Report date
2018-09-26
Termination date
2024-10-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dganya Bet, N/A, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2776-2018