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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 March 12, 2020
Create Date April 15, 2020
Recall Status1 Open3, Classified
Recall Number Z-1714-2020
Recall Event ID 85215
510(K)Number K971221  
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
Product VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
Code Information Item no. 454322. Lot no. B1908355. DI no. (01)29120017574488 (17) 200809 (10)B1908355.
Recalling Firm/
Manufacturer
Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Kevin Daugherty
704-261-7800
Manufacturer Reason
for Recall
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
FDA Determined
Cause 2
Process change control
Action Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112.
Quantity in Commerce 1,000,800 units.
Distribution US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GIM and Original Applicant = GREINER AMERICA, INC.
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