Class 2 Device Recall Prevent G Safety Winged Blood Collection Set Glide

• Date Initiated by Firm: September 22, 2017
• Create Date: July 26, 2018
• Recall Status: Open, Classified
• Recall Number: Z-2549-2018
• Recall Event ID: 80524
• 510(K)Number: K123987
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• Product: Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
• Code Information: Serial Number 102030178 Lots #: 160809
• FEI Number: 3008449424
• Recalling Firm/ Manufacturer: Guangzhou Improve Medical Instruments Co., Ltd.; NO. 102 Kaiyuan Avenue; Science City; Guangzhou China
• Manufacturer Reason for Recall: Leaks complaints.
• FDA Determined Cause: Under Investigation by firm
• Action: Several e-mails in early 2017 were sent to their only US consignee.
• Quantity in Commerce: 200,000
• Distribution: Kansas
• 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