Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1610-2024 — Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

U.S. FDA — Device Enforcement · United States · 2024-03-08 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1610-2024
Date of alert: 2024-03-08
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: ROUTE 92 MEDICAL INC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00853799007473

Reported risk: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1610-2024 — Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

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