Recall Z-0110-2024— Becton Dickinson & Co.

Name: FDA recall Z-0110-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-12

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2023-09-12. It names one FDA 510(k) clearance: K113558. Product: BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023. Reason: Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-12
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K113558 — BD BACTEC Plus Aerobic/F Culture Vials (plastic)Becton, Dickinson and Company·cleared 2012-03-16

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 BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023

Reason for recall

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

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