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U.S. Department of Health and Human Services

Class 2 Device Recall Temperature Sensing 100 Silicone Foley Catheter

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  Class 2 Device Recall Temperature Sensing 100 Silicone Foley Catheter see related information
Date Initiated by Firm December 02, 2019
Create Date January 13, 2020
Recall Status1 Terminated 3 on October 22, 2020
Recall Number Z-0809-2020
Recall Event ID 84510
510(K)Number K063442  
Product Classification Catheter, retention type, balloon - Product Code EZL
Product Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile
Catalog Number: 102201101463MD {Medline code 55346)

Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
Code Information Lot Number: V18046701
Recalling Firm/
Manufacturer		 Degania Silicone, Ltd.
Degania Bet
Dganya Bet Israel
Manufacturer Reason
for Recall		 Temperature deviation did not meet release specifications
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Q Medical Degania issued an "URGENT FIELD SAFETY NOTICE" letter dated 02-DEC-2019 via email, the letter states reason for recall, health risk and action to take: 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 form 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 facility 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, Customer complaints Officer, Tel: +972-529532059 E-mail: kkayam@qco.net
Quantity in Commerce 2080 units
Distribution US Distribution to IL
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 and Original Applicant = DEGANIA SILICONE, LTD.
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