Z-0829-03

C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be...

Name: Z-0829-03 C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be...
Creator: Steris Corp
Published: 2003-04-23
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2003-04-23 / Terminated / root cause: sterility

FDA source

Steris Corp began a recall of C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray... on 2003-04-23. The reason FDA records is "The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0829-03
Status: Terminated
Initiated: 2003-04-23
Posted: 2003-05-15
Terminated: 2004-02-05
Recalling firm: STERIS Corporation
Product: C1141 Flexible Endoscope Processing Container, designed to fit the Steris System I Processor. The unit may be sold individually or with the processing tray assembly (C1140).
Product code: MLR Sterilizer, Chemical
Reason for recall: The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.
Root cause tag: sterility
FDA root cause: Other
Action: The firm notified their customers by telephone and letter on 4/23/2003.
Quantity in commerce: 138 units
Distribution: The product was shipped to end-users located nationwide and worldwide.
Product codes and lots: All codes.

Product code MLR

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)