Class 2 Device Recall VacuFlow Safe

• Date Initiated by Firm: August 09, 2016
• Date Posted: September 22, 2016
• Recall Status: Terminated on January 23, 2017
• Recall Number: Z-2870-2016
• Recall Event ID: 74952
• 510(K)Number: K000714
• Product Classification: Needle, hypodermic, single lumen - Product Code FMI
• 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.
• Code Information: Model Number: MED 5223, Lot Number: 201505 l0
• Recalling Firm/ Manufacturer: Global Healthcare Inc; 11350 Old Roswell Rd; Suite 700; Alpharetta GA 30009-2291
• For Additional Information Contact: George Lamb; 770-522-7520
• Manufacturer Reason for Recall: The multi-sample needle retractable sheath may not fully retract over the needle during the changes of the blood collection tubes.
• FDA Determined Cause: Under Investigation by firm
• Action: The distributors were first notified on August 9, 2016 via phone to place product on hold. They were notified of the recall on August 10, 20l6 by email.
• Quantity in Commerce: 282 cartons (1000 units per carton)
• Distribution: FL
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FMI