Guangzhou Improve Medical Instruments Co., Ltd. recalls Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set ar…

Recall date

October 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2790-2018

FDA classification

Class II

Brand / firm

Guangzhou Improve Medical Instruments Co., Ltd.

Sold / distributed

Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.