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U.S. Department of Health and Human Services

Class 2 Device Recall Temperature sensing catheter

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  Class 2 Device Recall Temperature sensing catheter see related information
Date Initiated by Firm June 21, 2018
Create Date September 20, 2018
Recall Status1 Open3, Classified
Recall Number Z-2785-2018
Recall Event ID 80641
510(K)Number K063442  
Product Classification Catheter, retention type, balloon - Product Code EZL
Product Temperature sensing catheter 16FR, Catalogue Number 102201101663NU

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 V17015147
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 2		 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 1000
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EZL and Original Applicant = DEGANIA SILICONE, LTD.
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