EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 Indicated for use with high level disinfectant CIDEX OPA Con

FDA device recall Z-1368-2008 · posted 2008-08-08 · Terminated

Recall details

Recalling firm

Advanced Sterilization Products

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).

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FEB

Quantity affected

64 units

Distribution

Worldwide Distribution --- including USA and countries of Canada and Japan.

Date initiated

2008-02-13

Date posted

2008-08-08

Date terminated

2011-11-29

Location

Irvine, CA

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