ClearanceBrief
Recall Z-2549-2018 ยท FMI Needle, Hypodermic, Single Lumen

Guangzhou Improve Medical Instruments Co., Ltd.

Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO

DateSep 22, 2017
StatusOpen, Classified
ReasonLeaks complaints.
Root causeUnder Investigation by firm
ActionSeveral e-mails in early 2017 were sent to their only US consignee.
Quantity200,000
DistributionKansas
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K123987IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET
Innovative Medical Technologies, Inc., Aug 27, 2013