Route 92 Medical recall
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
Why was Route 92 Medical recalled?
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 00853799007442/ Lot # 23061601 24010306, 23081802, 24011801, 23100601, 24020801, 23102601
- Product
- Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Recalling firm
- ROUTE 92 MEDICAL INC
- Quantity
- 117 units
- 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
- Recall date
- May 1, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)