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Amsco Eagle

Steris Mexico, S. de R.L. de C.V. · Model 3017 · UDI-DI 00724995152017

FLF
1
510(k) clearances
66
Adverse events
8
Recalls
9
Facilities

Description

The Amsco Eagle EO Sterilizer, Tabletop 100% ethylene oxide (EO) gas sterilizer/aerator provides effective low-temperature sterilization of heat-sensitive items.

Recalls

DateFirmReason
2016-01-223M Company - Health Care Business3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of va
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-11-04Advanced Sterilization ProductsAdvanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after
2014-03-173M Company - Health Care BusinessRecently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi
2013-12-16Advanced Sterilization ProductsAdvanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possi
2012-09-133M Company - Health Care Business3M determined that the electrical grounding mechanism for the Steri-Vac 5XL and 8XL gas Sterilizer/Aerator did not meet all of the requirements of the standard in that the electric
2009-03-09Advanced Sterilization ProductsASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.