Class 2 Device Recall greiner bioone

• Date Initiated by Firm: December 09, 2021
• Create Date: January 18, 2022
• Recall Status: Terminated on October 10, 2023
• Recall Number: Z-0502-2022
• Recall Event ID: 89216
• 510(K)Number: K960857
• Product Classification: Tubes, vials, systems, serum separators, blood collection - Product Code JKA
• Product: greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
• Code Information: Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.
• Recalling Firm/ Manufacturer: Greiner Bio-One North America, Inc.; 4238 Capital Dr; Monroe NC 28110-7681
• For Additional Information Contact: Mr. Kevin Daugherty; 704-261-7800
• Manufacturer Reason for Recall: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
• FDA Determined Cause: Under Investigation by firm
• Action: The recalling firm initiated issuance of recall letters dated 12/9/2021 on the same date via email, phone, USPS, or UPS to their end-user customers. The letter explains the issue, the potential health hazard, and the necessary actions to be taken. The actions included to discontinue use of the affected product and isolate the products in their facility; assess risks and consequences for the use of the defective product in accordance with the consignee's procedures and take the appropriate action; and complete the attached Product Disposition Site Confirmation form and FAX it to the recalling firm. The form is a confirmation that the affected product has been discarded/destroyed. The product will be replaced by the recalling firm. The Customer Disposition form says if they have further distributed the product, they should provide the customer contact information to the recalling firm so that further follow-up can be made. For distributors. the letters were issued on 12/10/2021 via email. The email requests the distributor to provide a list of their customers to the recalling firm for further follow-up or to perform a subrecall themselves to the end-user customers. The distributor recall letter describes the problem and instructs the distributor to stop distributing the product and isolate it. A Product Disposition form was enclosed for completion to be returned via FAX or email. The recalling firm would then contact the distributor as to return or destruction for the product. The letter also informs the distributor it is a legal obligation to notify customers, therefore, they are requested to provide a list of their customers who have received the affected product, even though the cover email gives them the option of contacting the customers themselves.
• Quantity in Commerce: 889,200 pcs.
• Distribution: Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
• 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.