Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2549-2018Class II

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

Guangzhou Improve Medical Instruments Co., Ltd. / initiated 2017-09-22 / Open, Classified

Guangzhou Improve Medical Instruments Co., Ltd. began a recall of Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO on . FDA classified it as Class II and gives the reason as "Leaks complaints". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-2549-2018
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Guangzhou Improve Medical Instruments Co., Ltd.
Product
Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
Product code
FMI Needle, Hypodermic, Single Lumen
Reason for recall
Leaks complaints.
FDA root cause
Under Investigation by firm
Action
Several e-mails in early 2017 were sent to their only US consignee.
Quantity in commerce
200,000
Distribution
Kansas
Product codes and lots
Serial Number 102030178 Lots #: 160809

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2549-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2549-2018Class IIOngoingVoluntary: Firm initiated