Class I
Medical Device Recall: Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
ROUTE 92 MEDICAL INC · March 8, 2024
Reason for Recall
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
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
States Affected
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
Quantity Affected
200 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1613-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.