EvoTech Endoscope Cleaner & Reprocessor, Product Code 50004 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.
This recall has been terminated (originally issued August 8, 2008).
- Company
- Advanced Sterilization Products
- Recall Initiated
- February 13, 2008
- Posted
- August 8, 2008
- Terminated
- November 29, 2011
- Recall Number
- Z-1368-2008
- Quantity
- 64 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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).
Distribution
Worldwide Distribution --- including USA and countries of Canada and Japan.
Lot / Code Info
Product Code 50004; Serial Numbers: 50004001070080, 50004001070082, 50004001070083, 50004001070043, 50004001070044, 50004001070046, 50004001070048, 50004001070023, 50004001070024, 50004001070021, 50004001070075, 50004001070045, 50004001070078, 50004001070079, 50004001070107, 50004001070110, 50004001070081, 50004001070062, 50004001070064, 50004001070063, 50004001070034, 50004001070025, 50004001070029, 50004001070047, 50004001070049, 50004001070061, 50004001070087, 50004001070088, 50004001070084, 50004001070077, 50004001070076, 50004001070085, 50004001070086, 50004001070090, 50004001070091, 50004001070094, 50004001070089, 50004001070092, 50004001070098, 50004001070097, 50004001070099, 50004001070100, 50004001070101, 50004001070105, 50004001070106, 50004001070108, 50004001070109, 50004001070102, 50004001070103, 50004001070104, 50004001070020, 50004001070031, 50004001070035, 50004001070036, 50004001070039, 50004001070042, 50004001070059, 50004001070065, 50004001070071, 50004001070072, 50004001070073, 50004001070074, 50004001070114
Root Cause
Other
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.