Recall Z-0809-2020 ยท EZL Catheter, Retention Type, Balloon
Degania Silicone, Ltd.
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.
| Date | Dec 2, 2019 |
| Status | Terminated |
| Reason | Temperature deviation did not meet release specifications |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 2080 units |
| Distribution | US Distribution to IL |
| 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 |