FDA recall Z-1156-2023

Product

HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004

Reason for recall

Label with the incorrect component listed on the inner kit Tyvek header bag

Distribution

US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.

Key facts

Status

Ongoing

Initiation date

2022-12-22

Report date

2023-03-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1156-2023