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ROUTE 92 MEDICAL INC recalls Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices int
Recalled May 1, 2024 · FDA recall Z-1612-2024 · ROUTE 92 MEDICAL
Hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters · FDA Class I
Units
117 units
Sold at
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
Description
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Product
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Manufacturer(s)
ROUTE 92 MEDICAL INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →