FDA Enforcement
Class I
Ongoing
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Recall: Z-1610-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1610-2024
- 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 Access System, REF 7002, 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: 00853799007473/ Lot # 23051901
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
10 units