ROUTE 92 MEDICAL INC recalls Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional de…
- Recall date
- March 8, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1610-2024
- FDA classification
- Class I
- Brand / firm
- ROUTE 92 MEDICAL INC
- Sold / distributed
- 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
Why it was recalled
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
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