Z-1611-2024 Class I Ongoing
FDA device recall Z-1611-2024 was initiated by ROUTE 92 MEDICAL INC on March 8, 2024 and is designated Class I. Reason for recall: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters The recall status is ongoing. Affected quantity: 750 units.
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
- 750 units
Product Description
Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, 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: 00853799007497/ Lot # 223060102, 24010102, 23070501, 24010903, 23082802 24011606 , 23100404, 24012403 , 23110901