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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE Safety Blood Collection Set Luer Adapter

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 Class 2 Recall
VACUETTE Safety Blood Collection Set Luer Adapter
see related information
Date Posted February 15, 2013
Recall Status1 Terminated on October 29, 2013
Recall Number Z-0835-2013
Recall Event ID 64321
Premarket Notification
510(K) Number
K011786 
Product Classification Needle, Hypodermic, Single Lumen - Product Code FMI
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.
Code Information Lot No. 12H27
Recalling Firm/
Manufacturer
Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe, North Carolina 28110
For Additional Information Contact Manfred Abel
704-261-7823
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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FMI and Original Applicant = GREINER VACUETTE NORTH AMERICA, INC.
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