Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD 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.
Recall
- Recall Number
- Z-2775-2018
- Event Number
- 80641
- Firm
- Degania Silicone, Ltd. Degania Bet Dganya Bet Israel
- FEI Number
- 7682
- Product Code
- EZL
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- June 21, 2018
- Terminated
- October 25, 2024
Description
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD 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.
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.
Urgent Field Safety Notice letters were distributed to customers on 6/21/18. The letters instructed customers to perform the following: 1. Please forward this information to the immediate attention of the persons responsible for usage of the affected parts. Sub-recall must be initiated by your company to collect any distributed product from the suspected list. 2. Please fill in the attached Recall Response form and indicate the quantity of the affected product in your possession. 3. Promptly return the completed Recall Response form to Degania Silicone by e-mail: [email protected] Any affected product should be returned to Degania Facility at Rhode Island: Degania Silicone, Inc. 14 Thurber Blvd, Suite A Smithfield, RI 02917, US Contact name: Jackie Dubon e-mail: [email protected]
Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
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