ClearanceBrief
Recall Z-2750-2017 ยท FMF Syringe, Piston

Becton Dickinson & Company

BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection

DateSep 16, 2016
StatusTerminated
ReasonBD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Root causeProcess control
ActionBD sent recall letter/return response form on 9/16/2016.
Quantity340,000 units
DistributionNationwide Distribution
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K110771BD SINGLE USE, HYPODERMIC SYRINGE
Becton, Dickinson and Company, May 13, 2011