FDA Enforcement
Class II
Ongoing
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
·
Reported May 1, 2019
Enforcement
- Recall Number
- Z-1217-2019
- Event ID
- 80547
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- May 1, 2019
- Initiation Date
- September 22, 2017
- Classification Date
- April 24, 2019
- Address
- NO. 102 Kaiyuan Avenue, Science City, Guangzhou, N/A, N/A, 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.
Code Info
Serial # 102030178 / Lot # 160815
Distribution
US Nationwide distribution in the state of Kansas.
Quantity
550,000