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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 13x75 mm blue capwhite ring, sandwich tube, non

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  Class 2 Device Recall VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 13x75 mm blue capwhite ring, sandwich tube, non see related information
Date Initiated by Firm August 20, 2021
Create Date September 22, 2021
Recall Status1 Terminated 3 on October 04, 2023
Recall Number Z-2507-2021
Recall Event ID 88563
510(K)Number K971221  
Product Classification Tubes, vacuum sample, with anticoagulant - Product Code GIM
Product Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Code Information Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Technical Service
800-515-8112
Manufacturer Reason
for Recall		 Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
FDA Determined
Cause 2		 Under Investigation by firm
Action A letter was sent on August 20, 2021 with the following actions: Necessary actions: We need your assistance to address this recall. Please perform the following steps. " Stop using the above-mentioned product (concerned item/lot) immediately and isolate defective products in your facility. " Assess risks and consequences for the use of this defective product in accordance with your procedures and take appropriate action. " Complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 800.726.0052 or email to patech@gbo.com. This form is to confirm that you have discarded/destroyed all products from these items/lots. We will replace the product after the completed form is sent to Greiner. If you have additional questions, please call our Technical Service at 800-515-8112.
Quantity in Commerce 956,400
Distribution US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.
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 = GIM and Original Applicant = GREINER AMERICA, INC.
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