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
- 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