Reported Feb 15, 2017 · Terminated

QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)…

Stryker Leibinger GmbH & Co. KG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Leibinger GmbH & Co. KG · Botzinger Strasse 41 · Freiburg, N/A · N/A

Is this the product you have?

  • 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
Lot codes and dates
  • Part # 6630 QUINTUBE Monitor Pack Lots- M1305008, M1305009, M1305010, M1305011, M1309004, M1309005, M1309006, M1309007, M1309008, M1309009, M1309010, M1607009, M1607010, T1309003 Part # 6649 SPG Bulb Drain System, 4mm Flat w/Center Holes Lot - M1508003
Amount recalled
619

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

An incorrect sterility status on the label, non-sterile products labeled as sterile

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 27, 2017 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.