Recall Z-0696-2016— Global Healthcare Inc

Name: FDA recall Z-0696-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-06

Class II · Terminated

Class II FDA medical device recall by Global Healthcare Inc, initiated 2016-01-06, terminated 2016-03-25. It names one FDA 510(k) clearance: K083687. Product: ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China. Reason: Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard..

Recalling firm: Global Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2016-01-06
Terminated: 2016-03-25
Firm location: Alpharetta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K083687 — BAIXIN INTRAVASCULAR ADMINISTRATION SETAnhui Kangda Medical Products Co., Ltd.·cleared 2009-06-11

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

ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China

Reason for recall

Firm was notified of a potential product defect related to kinking (flattening) of anesthesia extension tubes which may represent a potential health hazard.

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