FDAFDA · Food and drugs·Recall number 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
Published February 15, 2017 · Recall initiated: January 3, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An incorrect sterility status on the label, non-sterile products labeled as sterile
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Leibinger GmbH & Co. KG
- Distributor
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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