Degania Silicone, Ltd. Degania Bet Dganya Bet Israel 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. Recall

Check Your Product

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

Reason for Recall

As stated by FDA

Temperature deviation did not meet release specifications

Recommended Action

Per FDA guidance

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

Distribution

As reported by FDA

IL