Recall Z-2790-2018 ยท FMI Needle, Hypodermic, Single Lumen
Guangzhou Improve Medical Instruments Co., Ltd.
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are 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. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blo
| Date | Oct 19, 2016 |
| Status | Open, Classified |
| Reason | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. |
| Root cause | Nonconforming Material/Component |
| Action | Several e-mails were sent between the manufacturer to the US distributor in 2016 |
| Quantity | 700,000 |
| Distribution | Puerto Rico |
| 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 |