Cook Incorporated Recall 90103
Description: Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Cook Incorporated Recall 90103 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1240-2022 |
| Event ID | 90103 |
| Event Description | Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) |
| Product Type | Devices |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| Quantity | 106,033 |
| Recall Reason | The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. |
| Device Classification | 20220615 |
| Device Code Info | Lots: 14212811 14215685 14212247 14212812 14212814 14215682 14361413 14361416 14285326 14285328 14285330 14297289 14361412 14445407 14444454 14477949 14477950 UDI: (01)00827002474994(17)261013(10)14212811 (01)00827002474994(17)261008(10)14215685 (01)00827002474987(17)261011(10)14212247 (01)00827002474987(17)261008(10)14212812 (01)00827002474994(17)261008(10)14212814 (01)00827002474994(17)261008(10)14215682 (01)00827002474994(17)261219(10)14361413 (01)00827002474994(17)261220(10)14361416 (01)00827002474987(17)261110(10)14285326 (01)00827002474987(17)261110(10)14285328 (01)00827002474994(17)261110(10)14285330 (01)00827002474994(17)261123(10)14297289 (01)00827002474987(17)261220(10)14361412 (01)00827002474987(17)270207(10)14445407 (01)00827002474994(17)270207(10)14444454 (01)00827002474987(17)270217(10)14477949 (01)00827002474994(17)270216(10)14477950 |
| Center Classification Date | 20220606 |
| Recall Initiation Date | 20220505 |
| Recalling Firm | Cook Incorporated |
| Initial Notification | Letter |
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