Recall Z-1714-2015— Advanced Sterilization Products

Name: FDA recall Z-1714-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-11

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2015-05-11, terminated 2016-07-06. It names one FDA 510(k) clearance: K140977. Product: EVOTECH Endoscope Cleaner and Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) 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 (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2015-05-11
Terminated: 2016-07-06
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K140977 — EVOTECH ECRAdvanced Sterilization Products·cleared 2014-12-22

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 Reprocessing System 208V, P/N 50004. The ASP EVOTECH ECR Endoscope Cleaner and Reprocessor is a washer/disinfector, which is indicated for use with high-level disinfectant CIDEX OPA Concentrate and an enzymatic detergent (CIDEZYME Gl) 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 (ECR) because it may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope.

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