Date Initiated by Firm |
August 09, 2016 |
Date Posted |
September 22, 2016 |
Recall Status1 |
Terminated 3 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 2 |
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
|
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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 and Original Applicant = MED-PRO TECHNOLOGIES, INC.
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