FDA recall Z-1217-2019

Guangzhou Improve Medical Instruments Co., Ltd. · Class II · 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.

Reason for recall

Complain due to the hub needle came out when the nurse draw the blood and removed the tube.

Distribution

US Nationwide distribution in the state of Kansas.

Key facts

Status
Ongoing
Initiation date
2017-09-22
Report date
2019-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Guangzhou, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2019