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Terminated

Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).

FDA Recall Z-1193-2007 · Posted 2007-08-23

Recalling FirmSteris Corp
Recall StatusTerminated
Product CodeFLE
Date Initiated2007-03-22
Date Terminated2010-09-28
Product Quantity78

Reason for Recall

The cables inside the pump conduit box may be exposed (not covered with wire nut and/or electrical tape) that could cause a potential electrical shock hazard.

Firm Action

By telephone 3/22/2007, customers were instructed to cease using the product and a service technician would be dispatched immediately to repair the unit.

Root Cause

Employee error

Distribution Pattern

Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010865AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURYSTERIS Corporation · 2001-05-31

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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