Recall Z-0604-2020— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2019-10-22, terminated 2020-05-06. It names one FDA 510(k) clearance: K964332. 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: Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-22
- Terminated
- 2020-05-06
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.