FDA recall Z-2751-2017

Product

BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

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 of 10-6.

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-2751-2017