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

Recall Z-1149-2017 — QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System

U.S. FDA — Device Enforcement · Germany · 2017-01-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1149-2017
Date of alert
2017-01-03
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Stryker Leibinger GmbH & Co. KG
Product category
device
Product type
Devices
Reported risk: An incorrect sterility status on the label, non-sterile products labeled as sterile
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.