Silk Road Medical Inc Recall 87196
Description: ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Silk Road Medical Inc Recall 87196 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1146-2021 |
| Event ID | 87196 |
| Event Description | ENROUTE Transcarotid Stent System REF SR-XXYY-CS |
| Product Type | Devices |
| Distribution | U.S.: AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: None |
| Quantity | Total = 455 systems |
| Recall Reason | Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. |
| Device Classification | 20210303 |
| Device Code Info | Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211130(10)17917092 Lot Number: 17917092 Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211231(10)17923717 Lot Number: 17923717 Catalog Number: SR1030CS UDI Code: (01)00811311020522(17)220131(10)17929776 Lot Number: 17929776 Catalog Number: SR1040CS UDI Code: (01)00811311020539(17)220131(10)17931107 Lot Number: 17931107 Catalog Number: SR0940CS UDI Code: (01)00811311020508(17)230131(10)301576 Lot Number: 301576 |
| Center Classification Date | 20210223 |
| Recall Initiation Date | 20210113 |
| Recalling Firm | Silk Road Medical Inc |
| Initial Notification | |
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