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U.S. Department of Health and Human Services

Class 2 Device Recall Temperature Sensing Foley Catheter

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  Class 2 Device Recall Temperature Sensing Foley Catheter see related information
Date Initiated by Firm March 17, 2020
Create Date April 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-1780-2020
Recall Event ID 85327
510(K)Number K063442  
Product Classification Catheter, retention type, balloon - Product Code EZL
Product Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Code Information Lot Numbers: V18022032 
Recalling Firm/
Manufacturer		 Degania Medical Devices Pvt. Ltd.
Plot No 251
Imt Manesar
Gurgaon India
Manufacturer Reason
for Recall		 Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An Urgent Field Safety Notice dated 3/17/20 was sent to customers. Please immediately follow the Required Customer Actions set fo rth below. 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. Please promptly return the completed Recall Response fo rm to Degania Silicone by e-mail: kkayam@qco.net. 4. The disposition of the recalled goods should be scrap. We would ask you to destruct the goods at your facil ity and send us the Scrap confirmation letter. Should you have any questions about this subject, please contact Degania Silicone: Degonia Silicone Ltd. Degania Bet, 1513000, ISRAEL Katia Kayam, Cust omer compla ints Officer Tel: +972-529532059 E-mail: kkayam@qco.net
Quantity in Commerce 1929
Distribution Worldwide distribution - US Nationwide distribution including state of IL and the country of 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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