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U.S. Department of Health and Human Services

Class 2 Device Recall LH Lithium Heparin tubes

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  Class 2 Device Recall LH Lithium Heparin tubes see related information
Date Initiated by Firm December 14, 2011
Date Posted February 22, 2012
Recall Status1 Terminated 3 on June 21, 2012
Recall Number Z-1081-2012
Recall Event ID 60748
510(K)Number K960857  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product LH Lithium Heparin tubes, Greiner bio-one, North America, 4238 Capital Drive, Monroe, NC 28110.

Venous blood collection tubes.
Code Information Item #456087, Lot #B07115 and B08116, Item #454244, #B091112, Item #456087CA, Lot #B091106, Item #456287, Lot #B101114, Item #454237, Lot #B091108 and Item #456287, Lot #B091110.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110
For Additional Information Contact Manfred Abel
704-261-7800
Manufacturer Reason
for Recall		 The lithium heparin tubes may have a contamination with EDTA potassium.
FDA Determined
Cause 2		 Material/Component Contamination
Action Greiner Bio-One sent a "RECALL OF LITHIUM HEPARIN TUBES WITH EDTA CONTAMINATION" letter dated December 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete an attached Product Disposition Site Confirmation Form and to fax the form to 800-726-0052. This form will confirm that customers have discarded/destroyed all affected product. The firm will replace the product after receipt of the form. Contact the firm at 800-515-8112 for questions regarding this recall.
Quantity in Commerce 2,082,000 pieces
Distribution Nationwide Distribution.
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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