Devicor Medical Products Inc Recall 90119
Description: HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Devicor Medical Products Inc Recall 90119 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1124-2022 |
| Event ID | 90119 |
| Event Description | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of DE, KY, NY, OH, WV. |
| Quantity | 90 devices |
| Recall Reason | Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3. |
| Device Classification | 20220601 |
| Device Code Info | UDI-DI: 00841911102472 Lot F12201281D |
| Center Classification Date | 20220523 |
| Recall Initiation Date | 20220330 |
| Recalling Firm | Devicor Medical Products Inc |
| Initial Notification | |
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