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

Recall Z-2636-2014 — Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.

U.S. FDA — Device Enforcement · United States · 2014-08-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2636-2014
Date of alert
2014-08-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Volcano Corporation
Product category
device
Product type
Devices
Reported risk: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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