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U.S. Department of Health and Human Services

Class 3 Device Recall VACUETTE

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  Class 3 Device Recall VACUETTE see related information
Date Initiated by Firm July 29, 2008
Date Posted November 07, 2008
Recall Status1 Terminated 3 on August 26, 2009
Recall Number Z-0215-2009
Recall Event ID 49371
510(K)Number K960857  
Product Classification Blood Collection Tube - Product Code JKA
Product VACUETTE¿, 2 ml Lithium Heparin Venous Blood Collection Tubes. Reference #454237, 13x75 green cap-white ring, 24 racks of 50 pcs (1200 pcs in total, non ridged, Sterile). Manufactured by: Greiner bio-one NA, Inc., 4238 Capital Drive, Monroe, NC 28110.

The Greiner Vacuette blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
Code Information Lot # B120703.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Manfred Abel
704-261-7800
Manufacturer Reason
for Recall		 Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and rack label information showed the correct information with 2 ml Lithium Heparin.
FDA Determined
Cause 2		 Labeling mix-ups
Action Consignees were notified by letter on 07/29/2008. Notification letters to distributors instructed them to stop distribution of the product and destroy all affected lots of the product. In addition, notification letters addressed to users instructed them to destroy and discard all products from the item and affected lots. The "Product Disposition Form" must be completed by the consignee and returned to Greiner Bio-One North America, Inc. For questions or additional information, contact Greiner Bio-One North America, Inc. at 704-261-7800.
Quantity in Commerce 33 cases (39,600 pieces)
Distribution Worldwide including USA (states of AK, AL, AR, CA, CO, DE, GA, ID, IL, IN, KS, LA, MA, MI, MO, MS, NC, ND, NE, NH, NY, OH, OK, OR, PA, RI, SC, SD, TX, VA, VT, WA, and WI) and country of Canada.
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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