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U.S. Department of Health and Human Services

Class 2 Device Recall Vacuette

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  Class 2 Device Recall Vacuette see related information
Date Initiated by Firm August 02, 2006
Date Posted September 13, 2006
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = GREINER AMERICA, INC.
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