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
Reported: February 15, 2017 Initiated: January 3, 2017 #Z-1149-2017
Product Description
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
Reason for Recall
An incorrect sterility status on the label, non-sterile products labeled as sterile
Details
- Recalling Firm
- Stryker Leibinger GmbH & Co. KG
- Units Affected
- 619
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Location
- Freiburg, N/A
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Stryker Leibinger GmbH & Co. KG. Units affected: 619.
Why was this product recalled? ▼
An incorrect sterility status on the label, non-sterile products labeled as sterile
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 15, 2017. Severity: Moderate. Recall number: Z-1149-2017.
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