FDA recall Z-0604-2020

Product

Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.

Reason for recall

Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.

Distribution

Worldwide distribution - US Nationwide distribution in the states of AL AR AZ CA CO DE FL GA HI IA ID IL IN KS LA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV, and country of Canada.

Key facts

Status

Terminated

Initiation date

2019-10-22

Report date

2019-12-11

Termination date

2020-05-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2020