Recall Z-1781-2020

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: Nonconforming Material/Component

Action taken

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