FDA recall Z-1531-2018

Becton Dickinson & Company · Class II · device

Product

BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)

Reason for recall

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

Distribution

US (Nationwide) Canada, Kuwait, Guyana, Guatemala, Taiwan, UK, Belgium, Sweden, Ireland, Israel, Spain, Switzerland and Lithuania

Key facts

Status
Terminated
Initiation date
2018-03-20
Report date
2018-05-02
Termination date
2020-04-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1531-2018