FDA recall Z-0502-2022

Greiner Bio-One North America, Inc. · Class II · device

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

Reason for recall

Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

Distribution

Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.

Key facts

Status
Terminated
Initiation date
2021-12-09
Report date
2022-01-26
Termination date
2023-10-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0502-2022