ClearanceBrief
Recall Z-2747-2017 ยท FMF Syringe, Piston

Becton Dickinson & Company

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

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.
Quantity22,400 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