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U.S. Department of Health and Human Services

Class 2 Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2

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 Class 2 Device Recall 3mL 9NC Coagulation Sodium Citrate 3.2see related information
Date Initiated by FirmJuly 02, 2012
Date PostedAugust 07, 2012
Recall Status1 Terminated 3 on June 11, 2013
Recall NumberZ-2154-2012
Recall Event ID 62595
510(K)NumberK971221 
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
Product3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.
Code Information Lot #B041206
FEI Number 3001451379
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110
For Additional Information ContactManfred Abel
704-261-7823
Manufacturer Reason
for Recall		Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionDistributors were notified by letter on 07/02/2012 and customers were sent a letter dated 07/05/2012. The letters identified the affected product and the reason for the recall. Distributors were asked to stop distributing the affected product and to complete the attached Product Disposition form. The form along with the affected product was to be returned to GBO. The firm will provide replacement stock or issue a credit once product return and receipt of the Product Disposition form has been confirmed. Customers were also asked to complete the Product Disposition Site Confirmation form and fax it back to Greiner Bio-One North America, Inc. at the number provided. The letter states that the firm will replace any affected product once the form is received. Questions should be directed to 800-515-8112.
Quantity in Commerce838.9 cases (1,006,700 pieces)
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GIM
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