Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Reported: May 1, 2024 Initiated: March 8, 2024 #Z-1612-2024
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
Details
- Recalling Firm
- ROUTE 92 MEDICAL INC
- Units Affected
- 117 units
- Distribution
- 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
- Location
- San Mateo, CA
Frequently Asked Questions
What product was recalled? ▼
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.. Recalled by ROUTE 92 MEDICAL INC. Units affected: 117 units.
Why was this product recalled? ▼
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Critical. Recall number: Z-1612-2024.
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