Z-0502-2022 Class II Terminated
FDA device recall Z-0502-2022 was initiated by Greiner Bio-One North America, Inc. on Dec 9, 2021 and is designated Class II. Reason for recall: Some of the blood collection tubes show clotting due to variation of Lithium Heparin. The recall status is terminated (terminated Oct 10, 2023). Affected quantity: 889,200 pcs..
Recall Details
- Product Type
- Devices
- Report Date
- Jan 26, 2022
- Initiation Date
- Dec 9, 2021
- Termination Date
- Oct 10, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 889,200 pcs.
Product Description
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
Reason for Recall
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Distribution Pattern
Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
Code Information
Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.