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Class 2 Device Recall VACUETTE |
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Date Initiated by Firm |
March 12, 2020 |
Create Date |
April 15, 2020 |
Recall Status1 |
Terminated 3 on August 31, 2022 |
Recall Number |
Z-1714-2020 |
Recall Event ID |
85215 |
510(K)Number |
K971221
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Product Classification |
Tubes, vacuum sample, with anticoagulant - Product Code GIM
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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
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For Additional Information Contact |
Kevin Daugherty 704-261-7800
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Manufacturer Reason for Recall |
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
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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
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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.
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510(K) Database |
510(K)s with Product Code = GIM and Original Applicant = GREINER AMERICA, INC.
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