Z-1614-2024 Class I Ongoing
FDA device recall Z-1614-2024 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: 19 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
- 19 units
Product Description
Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients.
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: 00853799007169/ Lot # 23112702 and 23112901