Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Reported: May 1, 2024 Initiated: March 8, 2024 #Z-1610-2024
Product Description
Route 92 Medical Full Length 070 Access System, REF 7002, 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.
Details
- Recalling Firm
- ROUTE 92 MEDICAL INC
- Units Affected
- 10 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 Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.. Recalled by ROUTE 92 MEDICAL INC. Units affected: 10 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-1610-2024.
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