Recall Z-1123-2013— Advanced Sterilization Products

Name: FDA recall Z-1123-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-22

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-03-22, terminated 2013-11-18. It names one FDA 510(k) clearance: K082392. Product: EVOTECH Endoscope Cleaner & 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) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-03-22
Terminated: 2013-11-18
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 & 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) has determined that a limited number of EVOTECH ECRs manufactured between 2011 and 2012 did not receive sufficient High Potential (HIPOT) DC voltage testing.

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