Class 2 Device Recall Silicone Temperature Sensor Foley Catheter

• Date Initiated by Firm: June 21, 2018
• Create Date: September 20, 2018
• Recall Status: Terminated on October 25, 2024
• Recall Number: Z-2776-2018
• Recall Event ID: 80641
• 510(K)Number: K063442
• Product Classification: Catheter, retention type, balloon - Product Code EZL
• 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.
• Code Information: S17006812
• FEI Number: 7682
• Recalling Firm/ Manufacturer: Degania Silicone, Ltd.; Degania Bet; Dganya Bet Israel
• Manufacturer 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.
• FDA Determined Cause: Employee error
• Action: 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: Katia@ds-il.com 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: jackie@deganiasilicone.com
• Quantity in Commerce: 100
• Distribution: Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = EZL