Recall Z-1240-2022 ยท KRD Device, Vascular, For Promoting Embolization
Cook Incorporated
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
| Date | May 5, 2022 |
| Status | Open, Classified |
| Reason | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| Root cause | Under Investigation by firm |
| Action | On May 5, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were advised that the presence of a small stainless steel cannula inside the loading cartridge may go undetected by the user. Customers were instructed to examine their inventory and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. Customers should return the product to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Please share this information with appropriate |
| Quantity | 106,033 |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160219 | Hilal Embolization MicroCoils Cook Incorporated, Aug 3, 2016 |