VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
FDA Recall Z-2485-2021 · Posted None
Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2021-08-13
Date Terminated2023-08-16
Product Quantity962,400 tubes
Reason for Recall
Blood collection tubes may experience a clotting issue.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.