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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE TUBE 6 ml K3E K3EDTA

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 Class 2 Device Recall VACUETTE TUBE 6 ml K3E K3EDTAsee related information
Date Initiated by FirmMarch 31, 2023
Date PostedMay 12, 2023
Recall Status1 Completed
Recall NumberZ-1583-2023
Recall Event ID 92025
510(K)NumberK960860 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Productgreiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Code Information Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
Manufacturer Reason
for Recall		Some of the tubes may be incorrectly labeled.
FDA Determined
Cause 2		Labeling Change Control
ActionThe recalling firm issued a letter dated 3/30/2023 on 3/31/2023 via email to their sole customer. The letter provided the reason for recall, contained detailed information regarding the complaint, provided photographs of the product which included incorrect tube labels and correct tube labels, investigation results, health risk analysis, and actions to be taken. Those actions included to discontinue use of the product immediately and isolate it, assess the risks and consequences of the use of the defective product in accordance with the customer's procedures and take appropriate action, and complete the attached Product Disposition Site Confirmation. The customer is to record the amount of product they have destroyed on the form and return it via FAX or email. It also instructs that if the customer has distributed this product elsewhere, they are requested to provide the recalling firm with the contact information for follow-up.
Quantity in Commerce36,000 pieces (30 full cases)
DistributionUS Nationwide distribution in the states of WI and GA.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = JKA
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