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Class 2 Device Recall VACUETTE Safety Blood Collection Set Luer Adapter |
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Date Initiated by Firm |
February 01, 2013 |
Date Posted |
February 15, 2013 |
Recall Status1 |
Terminated 3 on October 29, 2013 |
Recall Number |
Z-0835-2013 |
Recall Event ID |
64321 |
510(K)Number |
K011786
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Product Classification |
Needle, hypodermic, single lumen - Product Code FMI
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Product |
VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
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Code Information |
Lot No. 12H27 |
Recalling Firm/ Manufacturer |
Greiner Bio-One North America, Inc. 4238 Capital Dr Monroe NC 28110
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For Additional Information Contact |
Manfred Abel 704-261-7823
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Manufacturer Reason for Recall |
The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece.
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FDA Determined Cause 2 |
Other |
Action |
Greiner Bio-One sent a notification letter dated January 31, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to stop distributing the affected product, complete the attached Product Disposition form and fax to GBO at 800-726-0052 or email to patech@gbo.com. GBO will contact customers for the return of the affected product after receiving the attached Product Disposition form. Customers were requested to provide the names of customers who may have received the product. For questions call 800-515-8112. |
Quantity in Commerce |
192,000 pieces (192 cases) |
Distribution |
US Nationwide Distribution in the states of FL, IL, KY, NY, NC, PA, OH, TX, VA |
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.
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510(K) Database |
510(K)s with Product Code = FMI and Original Applicant = GREINER VACUETTE NORTH AMERICA, INC.
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