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U.S. Department of Health and Human Services

Class 2 Device Recall Medline Silicone Drain 15Fr 3/16" Full Fluted

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  Class 2 Device Recall Medline Silicone Drain 15Fr 3/16" Full Fluted see related information
Date Initiated by Firm June 28, 2019
Create Date August 12, 2019
Recall Status1 Terminated 3 on October 22, 2020
Recall Number Z-2266-2019
Recall Event ID 83287
Product Classification Catheter, irrigation - Product Code GBX
Product Medline Silicone Drain 15Fr 3/16" Full Fluted

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.
Code Information Lot Code: P1841839 
Recalling Firm/
Degania Silicone, Ltd.
Degania Bet
Dganya Bet Israel
Manufacturer Reason
for Recall
15FR and 19FR round fluted drain channel drain may break during use (mostly during removal) in connection point between clear tube and white profile part. requiring additional surgical intervention to remove the broken end from patient's body
FDA Determined
Cause 2
Process control
Action Degania Silicone Ltd. notified accounts by letter dated June 28, 2019 describing the problem, 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. Promptly return the completed Recall Response form to Degania Silicone by e-mail: kkayam@qco.net. 4. Disposition of the recalled product: - the preferred option for us is to scrap any recalled product at your facility. In this case we will require official Destruction Confirmation letter containing details of the scrapped product, signed by your company (the draft will be provided by request). - if the above option is not acceptable, we would ask to return any recalled product to our Rhode Island facility. Questions contact Degania Silicone: Degania Silicone Ltd. Degania Bet, 1513000, Israel Katia Kayam, Customer complaints Officer Tel: +972-529532059 E-mail: Kkayam@qco.net
Quantity in Commerce 200
Distribution Nationwide Distribution
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.