Recall Z-1150-2013— Advanced Sterilization Products

Name: FDA recall Z-1150-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-28

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-03-28, terminated 2013-08-22. It names one FDA 510(k) clearance: K082392. Product: EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.. Reason: Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Terminated: 2013-08-22
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082392 — EVOTECH ENDOSCOPE CLEANER AND REPROCESSORAdvanced Sterilization Products·cleared 2008-11-13

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, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the EVOTECH Endoscope Cleaner and Reprocessor (ECR) because they have received reports of smoke emanating from the system due to a circuit board malfunction that may occur in the Channel Control Manifold sub-assembly.

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