Recall Z-0474-2016— Becton Dickinson & Co.

Name: FDA recall Z-0474-2016
Creator: U.S. Food and Drug Administration
Published: 2015-06-29

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Co., initiated 2015-06-29, terminated 2016-08-12. It names one FDA 510(k) clearance: K951539. Product: Enterococcus Screen Agar QUAD Plate. Reason: The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life..

Recalling firm: Becton Dickinson & Co.
Classification: Class II
Status: Terminated
Initiated: 2015-06-29
Terminated: 2016-08-12
Firm location: Sparks, MD, United States

510(k) clearances named in this recall

1 on FDA's record

K951539 — ENTEROCOCCUS SCREENING MEDIUMBecton Dickinson Microbiology Systems·cleared 1995-06-13

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

Enterococcus Screen Agar QUAD Plate

Reason for recall

The affected expired lots of product may have exhibited breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life. The in-date product may also exhibit breakthrough growth of vancomycin susceptible Enterococcus facaelis ATCC 29212 near the end of shelf life.

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