|
This was two years ago, but there was a recall in 2008 due to the problems listed in the recall notice I copy/pasted below.
a) 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, Recall # Z-1368-2008;
b) 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, Recall # Z-1369-2008
CODE
a) 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;
b) Serial Numbers 50004002070001 and 50004002070004
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Sterilization Products, Irvine, CA, by letter on February 13, 2008.
Manufacturer: Jabil Circuit, Inc., Auburn Hills, MI. Firm initiated recall is ongoing.
REASON
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).
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
Nationwide and Internationally
Celeste Erickson (Administrator/Director/Manager/Owner/Exec. Officer) at
October 6, 2010 (1:12 pm) |
