ROUTE 92 MEDICAL INC Recall 94270
Description: Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
ROUTE 92 MEDICAL INC Recall 94270 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1613-2024 |
| Event ID | 94270 |
| Event Description | Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature. |
| Product Type | Devices |
| Distribution | US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV OUS: New Zealand |
| Quantity | 200 units |
| Recall Reason | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| Device Classification | 20240501 |
| Device Code Info | UDI: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707 |
| Center Classification Date | 20240424 |
| Recall Initiation Date | 20240308 |
| Recalling Firm | ROUTE 92 MEDICAL INC |
| Initial Notification | Letter |
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