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Class 2 Device Recall Prevent G Safety Winged Blood Collection Set Glide |
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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
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Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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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
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Manufacturer Reason for Recall |
Leaks complaints.
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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
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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.
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510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = INNOVATIVE MEDICAL TECHNOLOGIES, INC.
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