Class 2 Device Recall Vacuette

• Date Initiated by Firm: August 02, 2006
• Date Posted: September 13, 2006
• Recall Status: Terminated on January 11, 2007
• Recall Number: Z-1498-06
• Recall Event ID: 36027
• 510(K)Number: K971221
• Product Classification: blood collection tube - Product Code GIM
• Product: Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA
• Code Information: Item #454332, Lot #B050609
• Recalling Firm/ Manufacturer: Greiner Bio-One North America, Inc.; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Manfred Abel; 704-261-7823
• Manufacturer Reason for Recall: Coagulation tubes found with no additive.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter via fax starting 08/02/2006.
• Quantity in Commerce: 160 cases (192000 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