FDA recall Z-0698-2021

Product

AMT Male ENFit-to-Stepped Male (Christmas Tree) Adapter, Model Number ETRN102. Box PN TRN102, Box UDI (01)00842071109066(17)230901(10)200918-103, Pouch PN ETRN102, Pouch UDI (01)00842071108007(17)230901(10)200902-075

Reason for recall

The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label.

Distribution

US Nationwide distribution in the states of CA, GA, IL, MA, MO, PA, TX, VA. No foreign distribution.

Key facts

Status

Terminated

Initiation date

2020-11-10

Report date

2020-12-30

Termination date

2021-09-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Brecksville, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0698-2021