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

Recall Z-0054-2017 — Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter is a dual lumen catheter designed for use in the coronary and/or peripheral vasculature. The Twin-Pass catheter (Models 5200 and 5230) consists of an over-the-wir

U.S. FDA — Device Enforcement · United States · 2016-09-16 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0054-2017
Date of alert: 2016-09-16
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Vascular Solutions, Inc.
Product category: device
Product type: Devices

Reported risk: Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen.

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.

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