Recall Z-1610-2024 ยท QJP Catheter, Percutaneous, Neurovasculature
ROUTE 92 MEDICAL INC
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. 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 | 10 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
| K222743 | Route 92 Medical Full Length 070 Access System Route 92 Medical, Inc., Oct 4, 2022 |