Z-1369-2008

EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level...

Name: Z-1369-2008 EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level...
Creator: Advanced Sterilization Products
Published: 2008-02-13
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2008-02-13 / Terminated

FDA source

Advanced Sterilization Products began a recall of EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic... on 2008-02-13. The reason FDA records is "Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1369-2008
Status: Terminated
Initiated: 2008-02-13
Posted: 2008-08-08
Terminated: 2011-11-29
Recalling firm: Advanced Sterilization Products
Product: EvoTech Endoscope Cleaner and Reprocessor, Product Code 50004-002 Indicated for use with high level disinfectant CIDEX OPA Concentrate and an enzymatic detergent, CIDEZYME GI, to achieve cleaning and high level disinfection of heat sensitive semi-critical endoscopes.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
FDA root cause: Other
Action: Feburary 13, 2008 ASP issued an Urgent Product Recall Letter. ASP recommends that customers use an alternative reprocessing method until they return the system. However, if they do not have an alternate method for processing endoscopes and choose to continue using the EvoTech ECR System during this time, endoscopes processed through completed cycles in accordance with the User's Guide will be appropriately cleaned and highlevel disinfected. ASP is prepared to tailor an alternative solution to minimize the interruption to the customer's processing needs.
Quantity in commerce: 2 units
Distribution: Worldwide Distribution --- including USA and countries of Canada and Japan.
Product codes and lots: Product Code 50004-002; Serial Numbers 50004002070001 and 50004002070004

Product code FEB

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)