Recall Z-0877-2023 ยท NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Covidien LP
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions,
| Date | Jan 12, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| Reason | There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. |
| Root cause | Process design |
| Action | On December 7, 2022, Medtronic began notifying customers who had received the affected products. Customers were instructed to quarantine, discontinue use, and return unused products. Customers should forward the notification to those who need to be aware within the organization, and to any location where the devices have been distributed. |
| Quantity | 359,730 (23,003 US; 336,727 OUS) |
| Distribution | Worldwide distribution. US nationwide including Guam, USVI, and Puerto Rico; Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, Italy, Jamaica, K |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030209 | MAHURKAR OPLUS CATHETER, MODEL 13.5 FR The Kendall Company, May 13, 2003 |