FDA recall Z-0004-2020

The Metrix Company · Class II · device

Product

SECURE EVA - DUAL CHAMBER CONTAINER with Manifold, 1500mL, REF 66616 (Canadian distribution) - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Reason for recall

Potential for leaking product

Distribution

US Nationwide distribution including the states of PA, MA, IL CA.

Key facts

Status
Ongoing
Initiation date
2018-09-21
Report date
2019-10-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dubuque, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0004-2020