Device product
Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
Z-1217-2019
Product summary
- Event
- Event 80547
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 550,000
- Official record key
device-enforcement:Z-1217-2019
Official wording
Reason: Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Code information: Serial # 102030178 / Lot # 160815
Distribution pattern: US Nationwide distribution in the state of Kansas.
Derived failure modes
-
Unknown
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.