Recall Z-2758-2018— Degania Silicone, Ltd.
Class II · Terminated
Class II FDA medical device recall by Degania Silicone, Ltd., initiated 2018-06-21, terminated 2024-10-25. It names one FDA 510(k) clearance: K063442. Product: Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI 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: 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..
- Recalling firm
- Degania Silicone, Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-21
- Terminated
- 2024-10-25
- Firm location
- Dganya Bet, N/A, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Temperature Sensor Catheter 10FR, Catalogue Number 102201101063BI 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.