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Route 92 Medical Inc FDA Recalls
5 recalls on file across devices, 5 of them Class I and 5 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional deClass IMar 8, 2024Their is the potential for distal tip separation at the prox |
| Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventioClass IMar 8, 2024Their is the potential for distal tip separation at the prox |
| Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devClass IMar 8, 2024Their is the potential for distal tip separation at the prox |
| Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices intClass IMar 8, 2024Their is the potential for distal tip separation at the prox |
| Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices iClass IMar 8, 2024Their is the potential for distal tip separation at the prox |