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
Z-0502-2022
Product summary
- Event
- Event 89216
- Status
- Terminated
- Classification
- Class II
- Quantity
- 889,200 pcs.
- Official record key
device-enforcement:Z-0502-2022
Official wording
Reason: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
Code information: Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.
Distribution pattern: Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.