FDA Medical Device Recalls (openFDA)
Guangzhou Improve Medical Instruments Co., Ltd.: 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 number
- Z-1217-2019
- Recalling firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- 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.
- Status
- Open, Classified
- Initiated
- 2017-09-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
- Root cause
- Nonconforming Material/Component
- Action
- Several e-mails dated May 2017 thru June 2017between the manufacturer and the sole distributor for this lot are documented.
- Quantity
- 550,000
- Distribution
- US Nationwide distribution in the state of Kansas.
- Lot, serial or model codes
- Serial # 102030178 / Lot # 160815
- 510(k) numbers
- ["K123987"]
- PMA numbers
- not on file
- Product code
- FMI
- Firm FEI
- 3008449424
- Firm city
- Guangzhou
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28