FDA recall Z-3240-2017

The Metrix Company · Class II · device

Product

SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,

Reason for recall

The hot stamp label on the bag incorrectly states the material of the vinyl (bag) container. The bags are correctly made with PVC material, as ordered and as labeled on the inner and outer boxes.

Distribution

AZ, MA, IL, FL

Key facts

Status
Terminated
Initiation date
2017-09-13
Report date
2017-10-11
Termination date
2018-05-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dubuque, IA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3240-2017