FDA-Device2018-08-22Class II

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.

Guangzhou Improve Medical Instruments Co., Ltd.
Hazard

Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.

Sold states
Puerto Rico
Affected count
700,000
Manufactured in
NO. 102 Kaiyuan Avenue, Science City, Guangzhou, China
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2790-2018

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