Z-1613-2024 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
- 200 units
Product Description
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, 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: 00853799007534/ Lot # 23033001, 23073101, 23070305, 23081707