Degania Silicone, Ltd. Degania Bet Dganya Bet Israel Medline Silicone Drain 15Fr 3/16" Full Fluted PN: DYNJWE2188HB 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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