FDA recall Z-2048-2021

Product

Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120

Reason for recall

The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

Distribution

The products were distributed to the following US states: FL, IL, TN, WI

Key facts

Status

Terminated

Initiation date

2021-04-30

Report date

2021-07-21

Termination date

2024-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Medolla, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2048-2021