Recall Z-2776-2018 ยท EZL Catheter, Retention Type, Balloon
Degania Silicone, Ltd.
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.
| Date | Jun 21, 2018 |
| Status | Terminated |
| Reason | The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient. |
| Root cause | Employee error |
| Action | Urgent Field Safety Notice letters were distributed to customers on 6/21/18. The letters instructed customers to perform the following: 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. Promptly return the completed Recall Response form to Degania Silicone by e-mail: Katia@ds-il.com Any affecte |
| Quantity | 100 |
| Distribution | Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and 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 |