FDA Recall
Open, Classified
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.
Recall: Z-1217-2019
·
Initiated September 22, 2017
Recall
- Recall Number
- Z-1217-2019
- Event Number
- 80547
- Firm
- Guangzhou Improve Medical Instruments Co., Ltd. NO.
- FEI Number
- 3008449424
- Product Code
- FMI
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- September 22, 2017
- Address
- 102 Kaiyuan Avenue, Science City Guangzhou, China
Description
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
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Action
Several e-mails dated May 2017 thru June 2017between the manufacturer and the sole distributor for this lot are documented.
Distribution
US Nationwide distribution in the state of Kansas.
Quantity
550,000