Class 2 Device Recall

• Date Initiated by Firm: July 27, 2004
• Date Posted: August 10, 2004
• Recall Status: Terminated 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/ Manufacturer: Greiner VACUETTE North America; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Manfred Pillichshammer; 704-261-7823
• Manufacturer Reason for Recall: Coagulation tubes may not have received the proper fill of citrate solution.
• FDA Determined Cause: Other
• 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.