Recall Z-1217-2019 ยท FMI Needle, Hypodermic, Single Lumen
Guangzhou Improve Medical Instruments Co., Ltd.
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 th
| Date | Sep 22, 2017 |
| Status | Open, Classified |
| Reason | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. |
| Root cause | Nonconforming Material/Component |
| Action | Several e-mails dated May 2017 thru June 2017between the manufacturer and the sole distributor for this lot are documented. |
| Quantity | 550,000 |
| Distribution | US Nationwide distribution in the state of Kansas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123987 | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET Innovative Medical Technologies, Inc., Aug 27, 2013 |