Recall Z-2086-2019 ยท KOD Catheter, Urological
Teleflex Medical
Rusch EasyCath Kit
| Date | Jul 1, 2019 |
| Status | Terminated |
| Reason | Potential for product not to be sterile. |
| Root cause | Equipment maintenance |
| Action | Teleflex Medical notified customers on about 07/01/2019 via "Urgent Medical Device Recall Notification" letter. Distributors were instructed to: 1. Immediately discontinue distribution and quarantine any affected products. 2. Communicate this recall to any of your customers who have received product included within the scope of the recall using the provided customer letter. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. 4. To return recalled products to Teleflex Medical, |
| Quantity | 3,700 devices |
| Distribution | Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000070 | FLOCATH Rusch Intl., Feb 18, 2000 |