Class 2 Device Recall Improve Blood Collection Sets

• Date Initiated by Firm: October 19, 2016
• Create Date: August 12, 2018
• Recall Status: Open, Classified
• Recall Number: Z-2790-2018
• Recall Event ID: 80519
• 510(K)Number: K123987
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• 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.
• Code Information: Serial Number 102030132 Lots #'s: 20150210 and 20150410
• FEI Number: 3008449424
• Recalling Firm/ Manufacturer: Guangzhou Improve Medical Instruments Co., Ltd.; NO. 102 Kaiyuan Avenue; Science City; Guangzhou China
• Manufacturer Reason for Recall: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Several e-mails were sent between the manufacturer to the US distributor in 2016
• Quantity in Commerce: 700,000
• Distribution: Puerto Rico
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FMI