FDA Medical Device Recalls (openFDA)
Guangzhou Improve Medical Instruments Co., Ltd.: Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are 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. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
- Recall number
- Z-2790-2018
- Recalling firm
- Guangzhou Improve Medical Instruments Co., Ltd.
- Product
- Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are 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. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
- Status
- Open, Classified
- Initiated
- 2016-10-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
- Root cause
- Nonconforming Material/Component
- Action
- Several e-mails were sent between the manufacturer to the US distributor in 2016
- Quantity
- 700,000
- Distribution
- Puerto Rico
- Lot, serial or model codes
- Serial Number 102030132 Lots #'s: 20150210 and 20150410
- 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