Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Prevent G Safety Winged IMPROSAFE Blood Collection Setsee related information
Date Initiated by FirmSeptember 22, 2017
Create DateApril 24, 2019
Recall Status1 Open3, Classified
Recall NumberZ-1217-2019
Recall Event ID 80547
510(K)NumberK123987 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductPrevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is 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. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
Code Information Serial # 102030178 / Lot # 160815
FEI Number 3008449424
Recalling Firm/
Manufacturer		 Guangzhou Improve Medical Instruments Co., Ltd.
NO. 102 Kaiyuan Avenue
Science City
Guangzhou China
Manufacturer Reason
for Recall		Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionSeveral e-mails dated May 2017 thru June 2017between the manufacturer and the sole distributor for this lot are documented.
Quantity in Commerce550,000
DistributionUS Nationwide distribution in the state of Kansas.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FMI
-
-