FDA Enforcement
Class II
Terminated
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.
Recall: Z-1180-2018
·
Reported April 4, 2018
Enforcement
- Recall Number
- Z-1180-2018
- Event ID
- 78909
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 4, 2018
- Initiation Date
- September 18, 2017
- Classification Date
- March 26, 2018
- Termination Date
- February 4, 2019
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States
Description
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.
Reason
Increased amount of residual blood present on the top of stopper well after venipuncture
Code Info
All Lot Numbers Expiration Dates: November 30, 2017 - July 31, 2018 UDI No.: 50382903650434 50382903650441 50382903650458 50382903650472
Distribution
USA (nationwide)
Quantity
1,976,000 tubes