Z-1193-2007

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

Name: Z-1193-2007 Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm)
Creator: Steris Corp
Published: 2007-03-22
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2007-03-22 / Terminated / root cause: manufacturing process

FDA source

Steris Corp began a recall of Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm) on 2007-03-22. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1193-2007
Status: Terminated
Initiated: 2007-03-22
Posted: 2007-08-23
Terminated: 2010-09-28
Recalling firm: STERIS Corporation
Product: Amsco Century Medium Steam Sterilizer (26" x 37.5") (660 x 950mm).
Product code: FLE Sterilizer, Steam
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
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.
Quantity in commerce: 78
Distribution: Worldwide, including USA, Denmark, Belgium, Greece, India, and Russia.There are no Canadian accounts.
Product codes and lots: Prevac Steam Sterilizer, Model #'s V-136H, V-148H, V-160H, SV-148H, V-1264 & V-1263& SFPP Steam Sterilizer, Model #'s P-148H & P-160H. Code # B093934202, B093924204, B09324223, B093924225, B093924227, B093924229, B093924233, B093924244, B093924246, B093924248, B093924250, B093924286, B093924288, B093924296, B093924307, B093924309, B093924310, B093924434, B093924476, B093927301, B093927302, B093927322, B300903936

Product code FLE

K010865Class IIAmsco Century Medium Sterilizer, Model CenturySTERIS Corporation / cleared 2001-05-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)