Steris AMSCO Eagle 3000 Prevacuum Sealer (2019-10-23)

Starting date:

October 23, 2019

Posting date:

November 8, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71557

Last updated: 2019-11-08

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  Reason
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  Affected products

Affected Products

Steris AMSCO Eagle 3000 Prevacuum Sealer

Reason

Steris has identified that a small number of preventive maintenance kits for the Eagle 3000 small sterilizer were assembled with a 100 psig safety valve instead of a 40 psig valve, potentially resulting in the 100 psig valves being installed on sterilizers in the field. Use of the incorrect valve could result in the improbable scenario of water and steam leaking from the unit's fittings, or accumulation of steam in the chamber. Steris has not received any reports of adverse events related to the issue described above.

Affected products