Recall Z-1149-2017
Stryker Leibinger GmbH & Co. KG · initiated January 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
An incorrect sterility status on the label, non-sterile products labeled as sterile
FDA-determined cause: Labeling mix-ups
Action taken
Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.
Details
- Recall number
- Z-1149-2017
- Initiated
- January 3, 2017
- Posted by FDA
- February 8, 2017
- Terminated
- July 27, 2017
- Product code
- GCY – Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Quantity
- 619
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
- Recalling firm
- Stryker Leibinger GmbH & Co. KG, Freiburg
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1150-2017 Class II | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set…An incorrect sterility status on the label, non-sterile products labeled as sterile | 01/03/2017Terminated |