FDA Enforcement
Class I
Ongoing
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Recall: Z-1611-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1611-2024
- Event ID
- 94270
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- ROUTE 92 MEDICAL INC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- March 8, 2024
- Classification Date
- April 24, 2024
- Address
- 155 Bovet Rd Ste 100, N/A, San Mateo, CA, 94402-3151, United States
Description
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reason
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Code Info
UDI: 00853799007497/ Lot # 223060102, 24010102, 23070501, 24010903, 23082802 24011606 , 23100404, 24012403 , 23110901
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
750 units