Recall Z-2386-2021
Cardiovascular Systems Inc · initiated July 21, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Codes / lots: Lot 340931
Reason for recall
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.
FDA-determined cause: Process control
Action taken
The firm notified its consignees by letter on 07/1/2021. The notice explained the issue and requested the return of the affected products.
Details
- Recall number
- Z-2386-2021
- Initiated
- July 21, 2021
- Terminated
- March 18, 2026
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
- Recalling firm
- Cardiovascular Systems Inc, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2385-2021 Class II | DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF…There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm… | 07/21/2021Terminated |