Prevent 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.
FDA Recall Z-1217-2019 · Posted None
Recalling FirmGuangzhou Improve Medical Instruments Co., Ltd.
Recall StatusOpen, Classified
Product CodeFMI
Date Initiated2017-09-22
Product Quantity550,000
Reason for Recall
Complain due to the hub needle came out when the nurse draw the blood and removed the tube.
Firm Action
Several e-mails dated May 2017 thru June 2017between the manufacturer and the sole distributor for this lot are documented.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the state of Kansas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.