Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall VACUETTEsee related information
Date Initiated by FirmMarch 12, 2020
Create DateApril 15, 2020
Recall Status1 Terminated 3 on August 31, 2022
Recall NumberZ-1714-2020
Recall Event ID 85215
510(K)NumberK971221 
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
ProductVACUETTE 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 ContactKevin 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
ActionGreiner 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 Commerce1,000,800 units.
DistributionUS 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 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
-
-