Cardiovascular Systems Inc Recall 88388
Description: DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
Cardiovascular Systems Inc Recall 88388 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2385-2021 |
| Event ID | 88388 |
| Event Description | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 |
| Product Type | Devices |
| Distribution | US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL |
| Quantity | 8 units |
| Recall Reason | There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa. |
| Device Classification | 20210908 |
| Device Code Info | Lot 340925 |
| Center Classification Date | 20210828 |
| Recall Initiation Date | 20210721 |
| Recalling Firm | Cardiovascular Systems Inc |
| Initial Notification | Letter |
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