Recall Z-2056-2018— Becton Dickinson & Company

Name: FDA recall Z-2056-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-13

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-02-13, terminated 2020-03-09. It names one FDA 510(k) clearance: K023075. Product: BD VACUTAINER PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986. Reason: Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube.

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Terminated: 2020-03-09
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K023075 — BD VACUTAINER PLUS SST SERUM SEPARATOR TUBEBd Vacutainer Systems Preanalyical Solutions·cleared 2002-11-25

K-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 PLUS SST Tube with HEMOGARD closure 13x100mm 5.0ml PLBL Gold, Catalog No. 367986

Reason for recall

Tubes may exhibit stopper creepout/pullout, where the stopper dissociates from the tube

Data sourced from openFDA. This site is unofficial and independent of the FDA.