Recall Z-2549-2018— Guangzhou Improve Medical Instruments Co., Ltd.

Name: FDA recall Z-2549-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-22

Class II · Ongoing

Class II FDA medical device recall by Guangzhou Improve Medical Instruments Co., Ltd., initiated 2017-09-22. It names one FDA 510(k) clearance: K123987. Product: Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO. Reason: Leaks complaints..

Recalling firm: Guangzhou Improve Medical Instruments Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2017-09-22
Firm location: Guangzhou, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K123987 — IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SETInnovative Medical Technologies, Inc.·cleared 2013-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Leaks complaints.

Data sourced from openFDA. This site is unofficial and independent of the FDA.