Recall Z-2870-2016— Global Healthcare Inc

Name: FDA recall Z-2870-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-09

Class II · Terminated

Class II FDA medical device recall by Global Healthcare Inc, initiated 2016-08-09, terminated 2017-01-23. It names one FDA 510(k) clearance: K000714. Product: MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.. Reason: The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes..

Recalling firm: Global Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-09
Terminated: 2017-01-23
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K000714 — VACUFLOW+SAFE BLOOD COLLECTION SET AND VACUFLOW+SAFE WITH HOLDER BLOOD COLLECTION SETMed-Pro Technologies, Inc.·cleared 2000-12-21

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

MED 5223 - VacuFlow Safe, Multi-Sample Blood Collection Set With Luer Adapter Tube 12", Sterile, Rx only, Distributed by Tanner Scientific, Sarasota, FGL 34243 Made in China.

Reason for recall

The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.

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