Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO recall — FDA Z-1612-2024
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Overview of recall records associated with ROUTE 92 MEDICAL Inc., including dates, categories and classifications where available.
Classification mix: Class I: 5.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
This page summarizes recall records in which the official source identifies ROUTE 92 MEDICAL Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.