VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
- Recall Initiated
- August 13, 2021
- Terminated
- August 16, 2023
- Recall Number
- Z-2485-2021
- Quantity
- 962,400 tubes
- Firm Location
- Monroe, NC
Reason for Recall
Blood collection tubes may experience a clotting issue.
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.