Atlas FDA

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

FDA device recall Z-1193-2007 · posted 2007-08-23 · Terminated

Recall details

Recalling firm
Steris Corp
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.
Action taken
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
Status
Terminated
Product code
FLE
Quantity affected
78
Distribution
Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
Date initiated
2007-03-22
Date posted
2007-08-23
Date terminated
2010-09-28
Location
Mentor, OH

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Related 510(k) clearances

RecordFirmDate
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY (K010865)STERIS Corporation2001-05-31