Recall Z-0604-2020 ยท FLE Sterilizer, Steam
Steris Corporation
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 s
| Date | Oct 22, 2019 |
| Status | Terminated |
| Reason | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers. |
| Root cause | Packaging |
| Action | On October 22, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating: URGENT DEVICE FIELD CORRECTION ATTN: MATERIALS MANAGEMENT OR STERILE PROCESSING DEPARTMENT RE: Pressure Safety Valve Kit to Eagle 3000 Small Sterilizers Dear Valued STERIS Customer: STERIS Corporation is voluntarily implementing a field correction for Eagle 3000 Small Sterilizers that may have had an incorrect pressure safety valve installed. Safety valve kits with incorrect valves were shipped between July 17, 2019 - August 28, 2019. Our records indicate that your facility was shipped |
| Quantity | 236 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964332 | EAGLE CENTURY STEAM STERILIZER Amsco Intl., Inc., Jun 1, 1998 |