Device product
BD Vacutainer¿ Barricor" Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use, Catalog Numbers: 365043, 365044, 365045 & 365047 Used to collect, separate, process, transport and store venous blood samples for use in chemistry determinations, therapeutic drug monitoring and zinc testing in plasma for in vitro diagnostic use.
Z-1180-2018
Product summary
- Event
- Event 78909
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,976,000 tubes
- Official record key
device-enforcement:Z-1180-2018
Official wording
Reason: Increased amount of residual blood present on the top of stopper well after venipuncture
Code information: All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472
Distribution pattern: USA (nationwide)
Derived failure modes
-
Unknown
Increased amount of residual blood present on the top of stopper well after venipuncture