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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cappink ring, nonridged

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  Class 2 Device Recall VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cappink ring, nonridged see related information
Date Initiated by Firm August 13, 2021
Create Date September 24, 2021
Recall Status1 Terminated 3 on August 16, 2023
Recall Number Z-2485-2021
Recall Event ID 88511
510(K)Number K971236  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Code Information Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.
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		 Blood collection tubes may experience a clotting issue.
FDA Determined
Cause 2		 Process control
Action A distributor and customer letter dated 08/12/2021 was issued to affected consignees. Customers are advised to stop using the recalled product immediately and quarantine affected product within the facility. Customers are asked to complete a Product Disposition form and return to the recalling firm. The firm issued additional letters dated 9/10/2021 on 9/13/2021 via email to distributors and via USPS to other customers informing them of an additional lot number of product that is affected. The letters provide similar instructions as the initial letter.
Quantity in Commerce 962,400 tubes
Distribution Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
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 = JKA and Original Applicant = GREINER AMERICA, INC.
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