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U.S. Department of Health and Human Services

Class 2 Device Recall Vacuette 4ml EDTA DK2 tube

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  Class 2 Device Recall Vacuette 4ml EDTA DK2 tube see related information
Date Initiated by Firm August 12, 2011
Date Posted November 14, 2011
Recall Status1 Terminated 3 on March 12, 2012
Recall Number Z-0184-2012
Recall Event ID 59919
510(K)Number K971236  
Product Classification blood collection tube - Product Code JKA
Product Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.
Code Information Item #454209, Lot #B051111.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110
For Additional Information Contact Manfred Abel
704-261-7800
Manufacturer Reason
for Recall		 Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach¿ and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.
Quantity in Commerce 504,000 pieces
Distribution Nationwide.
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 = JKA and Original Applicant = GREINER AMERICA, INC.
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