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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 27, 2004
Date Posted August 10, 2004
Recall Status1 Terminated 3 on October 29, 2004
Recall Number Z-1331-04
Recall Event ID 29652
510(K)Number K971221  
Product Classification Tubes, Vacuum Sample, With Anticoagulant - Product Code GIM
Product Greiner bio-one, VACUETTE¿ TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.
Code Information Item no. 454332, Lot number B040404
Recalling Firm/
Greiner VACUETTE North America
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Manfred Pillichshammer
Manufacturer Reason
for Recall
Coagulation tubes may not have received the proper fill of citrate solution.
FDA Determined
Cause 2
Action Consignees were notified by letter on 7/28/2004.
Quantity in Commerce 314 cases (376,800 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 = GIM and Original Applicant = GREINER AMERICA, INC.