ClearanceBrief
Recall Z-1440-2017 ยท FMI Needle, Hypodermic, Single Lumen

Becton Dickinson & Company

Eclipse Hypodermic Needle

DateDec 20, 2016
StatusTerminated
ReasonBD is initiating a Product Advisory for the Eclipse Hypodermic Needle because of safety complaints covering disengagement and needlestick injuries.
Root causeDevice Design
ActionBD sent a Product Advisory Notice and Business Reply Card dated December 29, 2016 via UPS Ground delivery to their affected customers.
Quantity263 mm units
DistributionUS Nationwide
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K161170BD Eclipse Hypodermic Needle
Becton, Dickinson and Company, May 27, 2016