Recall Z-1217-2019— Guangzhou Improve Medical Instruments Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Guangzhou Improve Medical Instruments Co., Ltd., initiated 2017-09-22. It names one FDA 510(k) clearance: K123987. 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: Complain due to the hub needle came out when the nurse draw the blood and removed the tube..
- Recalling firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2017-09-22
- Firm location
- Guangzhou, N/A, China
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Data sourced from openFDA. This site is unofficial and independent of the FDA.