FDA Enforcement Class II Ongoing

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

Recall: Z-2549-2018 · Reported August 1, 2018

Enforcement

Recall Number
Z-2549-2018
Event ID
80524
Classification
Class II
Status
Ongoing
Product Type
Devices
Firm
Guangzhou Improve Medical Instruments Co., Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
E-Mail
Report Date
August 1, 2018
Initiation Date
September 22, 2017
Classification Date
July 26, 2018
Address
NO. 102 Kaiyuan Avenue, Science City, Guangzhou, N/A, N/A, China

Description

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

Reason

Leaks complaints.

Code Info

Serial Number 102030178 Lots #: 160809

Distribution

Kansas

Quantity

200,000