MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions,
FDA device recall Z-0877-2023 · posted 2023-01-12 · Open, Classified
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Open, Classified
- Product code
- NIE
- Quantity affected
- 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 Republi
- Date initiated
- 2022-12-07
- Date posted
- 2023-01-12
- Location
- Mansfield, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAHURKAR OPLUS CATHETER, MODEL 13.5 FR (K030209) | The Kendall Company | 2003-05-13 |