Route 92 Medical recalls full-length 070 access systems (REF 7002) due to potential distal tip separation at the proximal marker band, which could cause injury during medical procedures.
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
Route 92 Medical is recalling their Full Length 070 Access System (REF 7002) because there's a risk of the catheter tip separating at the marker band during use. This could lead to complications in medical procedures if not addressed.
The delivery catheters in this system could separate at the proximal marker band during medical procedures. This separation might cause injury or complications if the catheter moves unexpectedly during treatment.
Healthcare professionals using this system for neurovascular procedures are most at risk. Patients receiving these procedures may also be affected if the system is used incorrectly.
Check for the product name 'Route 92 Medical Full Length 070 Access System' with reference number REF 7002. The system is labeled as Rxonly, SterileEO, and sold with UDI: 00853799007473/ Lot # 23051901.
Verify the product name, reference number REF 7002, and UDI code 00853799007473/ Lot # 23051901 to confirm if it's affected.
The recall states there's a potential for distal tip separation, so it's not recommended for use until the issue is resolved.
Check for the product name 'Route 92 Medical Full Length 070 Access System' with reference number REF 7002 and UDI: 00853799007473/ Lot # 23051901.
The recall does not specify a remedy, so contact the manufacturer for guidance on next steps.
We’ve drafted a message you can send Route 92 Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1610-2024 — Route 92 Medical Route 92 Medical Hello, I own a Route 92 Medical that is covered by recall Z-1610-2024 from Route 92 Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
