Z-1149-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 15, 2017
- Initiation Date
- January 3, 2017
- Termination Date
- July 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 619
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
Distribution Pattern
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Code Information
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