Recall Z-1180-2018— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2017-09-18, terminated 2019-02-04. It names one FDA 510(k) clearance: K160657. 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.. Reason: Increased amount of residual blood present on the top of stopper well after venipuncture.
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-09-18
- Terminated
- 2019-02-04
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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 for recall
Increased amount of residual blood present on the top of stopper well after venipuncture
Data sourced from openFDA. This site is unofficial and independent of the FDA.