FDA Enforcement
Class II
Completed
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Recall: Z-1583-2023
·
Reported May 24, 2023
Enforcement
- Recall Number
- Z-1583-2023
- Event ID
- 92025
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Greiner Bio-One North America, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 24, 2023
- Initiation Date
- March 31, 2023
- Classification Date
- May 12, 2023
- Address
- 4238 Capital Dr, N/A, Monroe, NC, 28110-7681, United States
Description
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Reason
Some of the tubes may be incorrectly labeled.
Code Info
Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
Distribution
US Nationwide distribution in the states of WI and GA.
Quantity
36,000 pieces (30 full cases)