Z-3124-2011

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By...

Name: Z-3124-2011 SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By...
Creator: Steris Corporation
Published: 2011-08-11
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2011-08-11 / Terminated

FDA source

Steris Corporation began a recall of SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage... on 2011-08-11. The reason FDA records is "STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3124-2011
Status: Terminated
Initiated: 2011-08-11
Posted: 2011-09-01
Terminated: 2013-03-19
Recalling firm: STERIS Corporation
Product: SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories.
Product code: MLR Sterilizer, Chemical
Reason for recall: STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
FDA root cause: Other
Action: STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828.
Quantity in commerce: 2,235 units
Distribution: Worldwide Distribution - USA (nationwide) and the country of Bahrain.
Product codes and lots: Model # P6500, S/N: 400001 through 405005

Product code MLR

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)