Z-1610-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10 units
Product Description
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reason for Recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Distribution Pattern
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
Code Information
UDI: 00853799007473/ Lot # 23051901