STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
This recall has been completed (originally issued July 21, 2021).
- Company
- Cardiovascular Systems Inc
- Recall Initiated
- July 21, 2021
- Recall Number
- Z-2386-2021
- Quantity
- 8 units
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide Distribution - AR, OH, SC, WA, PA, WI, IA, and FL
Lot / Code Info
Lot 340931
Root 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.
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