Z-1612-2024 Class I Ongoing
FDA device recall Z-1612-2024 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: 117 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
- 117 units
Product Description
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. 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: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601