FDA recall Z-2747-2017

Becton Dickinson & Company · Class II · device

Product

BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062

Reason for recall

BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.

Distribution

Nationwide Distribution

Key facts

Status
Terminated
Initiation date
2016-09-16
Report date
2017-07-26
Termination date
2018-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2747-2017