Recall Z-2043-2020 ยท EZL Catheter, Retention Type, Balloon
Medline Industries Inc
SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml - Product Usage: Medline Silicone Foley catheter is a flexible tubular device that is inserted through the urethra and used to drain urine into a collection device.
| Date | May 28, 2019 |
| Status | Terminated |
| Reason | Loose silicone particulate was found to be present on the shaft of the silicone catheters. |
| Root cause | Manufacturing material removal |
| Action | Medline Industries, Inc. sent formal letters with response forms to each consignee affected via 1st class mail on May 28, 2019. Each consignee was also provided with a response form to return via fax or email. The recalled product that is will be quarantined at the corporate office located at Three Lakes Drive, Northfield, IL 60093-2753 pending destruction. |
| Quantity | 0 |
| Distribution | US Nationwide distribution including in the states of CO, IL, KY, MO, NJ, OR, TN, TX, VA, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.