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

Recall Z-1845-2015 — Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure measurements provide

U.S. FDA — Device Enforcement · United States · 2015-06-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1845-2015
Date of alert
2015-06-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Volcano Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50004551
Reported risk: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.