Recall Z-1612-2024 ยท QJP Catheter, Percutaneous, Neurovasculature
ROUTE 92 MEDICAL INC
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
| Date | Apr 24, 2024 (initiated Mar 8, 2024) |
| Status | Open, Classified |
| Reason | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| Root cause | Process control |
| Action | On March 12, 2024 Route 92, issued a Urgent Medical Device recall notification to affected consignees via Mail and EMail. Route 92 asked consignees to take the following actions: Ensure all of your SUMMIT MAX inventory including the affected 070 Reperfusion Systems is in a secure, quarantined location. 2. Complete the Acknowledgement Form in Attachment 2 and return to Route 92 Medical by one of the following methods: Email-FieldActions@route92medical.com/Standard Mail - Attention Line: Tenzing 7 fiedl action, 155 Bovet Road Suite 100, San Mateo, CA 94402 Please return the Acknowledgement Form |
| Quantity | 117 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203043 | Route 92 Medical 070 Access System Route 92 Medical, Inc., Nov 11, 2020 |