FDA recall Z-1210-2019

Product

SmartSite Syringe Administration Set-Product Package Size 50, Catalog Number: 10798696

Reason for recall

Leaking of the Smartsite Syringe Administration Set. May result in delay or interruption of infusion, under-infusion, contamination of the fluid path and HCP exposure to infusates.

Distribution

US Nationwide Distribution in the states of AR, NH, NC

Key facts

Status

Terminated

Initiation date

2019-02-28

Report date

2019-07-03

Termination date

2020-07-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1210-2019