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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Prevent G Safety Winged Blood Collection Set Glide see related information
Date Initiated by Firm September 22, 2017
Create Date July 26, 2018
Recall Status1 Open3, 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
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 2		 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 and Original Applicant = INNOVATIVE MEDICAL TECHNOLOGIES, INC.
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