Recall Z-1532-2018— Becton Dickinson & Company

Name: FDA recall Z-1532-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-20

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2018-03-20, terminated 2020-04-20. It names one FDA 510(k) clearance: K030573. Product: BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344. Reason: Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2018-03-20
Terminated: 2020-04-20
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K030573 — BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341Bd Vacutainer Systems Preanalyical Solutions·cleared 2003-05-08

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¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344

Reason for recall

Products do not meet the labeled sterility claim of a Sterility Assurance Level (SAL) 10-6.

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