Device product
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
Z-1149-2017
Product summary
- Event
- Event 76146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 619
- Official record key
device-enforcement:Z-1149-2017
Official wording
Reason: An incorrect sterility status on the label, non-sterile products labeled as sterile
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
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Derived failure modes
-
Sterility assurance
non-sterile products labeled as sterile