Recall Z-0965-2017— Advanced Sterilization Products

Name: FDA recall Z-0965-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-27

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2016-09-27, terminated 2017-04-17. It names 5 FDA 510(k) clearances: K152189, K140977, K082392 and 2 more. Product: EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.. Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2016-09-27
Terminated: 2017-04-17
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K152189 — EVOTECH ECRAdvanced Sterilization Products (Asp)·cleared 2016-07-20
K140977 — EVOTECH ECRAdvanced Sterilization Products·cleared 2014-12-22
K082392 — EVOTECH ENDOSCOPE CLEANER AND REPROCESSORAdvanced Sterilization Products·cleared 2008-11-13
K061889 — BIOSTAR OIA SHIGATOXInverness Medical-Biostar, Inc.·cleared 2006-12-12
K040883 — EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEMAdvanced Sterilization Products·cleared 2005-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EVOTECH Endoscope Cleaner and Reprocessor System 208V, Product Code: 50004 The EVOTECH ECR Endoscope Cleaner and Reprocessor, a washer/disinfector, is indicated for use with high-level disinfectant CIDEX OPA Concentrate Solution and an enzymatic detergent (CIDEZYME XTRA) to achieve cleaning and high level disinfection of heat sensitive (>60¿C} semi-critical endoscopes.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor System because the hose may come loose and cause a leak.

Data sourced from openFDA. This site is unofficial and independent of the FDA.