Recall Z-1780-2020 ยท EZL Catheter, Retention Type, Balloon
Degania Medical Devices Pvt. Ltd.
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101063MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
| Date | Mar 17, 2020 |
| Status | Terminated |
| Reason | Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 1929 |
| Distribution | Worldwide distribution - US Nationwide distribution including state of IL and the country of Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063442 | ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR Degania Silicone , Ltd., Mar 26, 2007 |