FDAFDA · Food and drugs·Recall number Z-1612-2024
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Published May 1, 2024 · Recall initiated: March 8, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ROUTE 92 MEDICAL INC
- Distributor
- 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
- Lot
- UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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