FDA recall Z-2700-2020

Product

InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

Reason for recall

A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.

Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Mexico, and United Arab Emirates.

Key facts

Status

Terminated

Initiation date

2020-06-26

Report date

2020-08-05

Termination date

2020-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2700-2020