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Z-2130-2016 Class II Terminated

Recalled by Custom Ultrasonics, Inc. — Ivyland, PA

FDA device recall Z-2130-2016 was initiated by Custom Ultrasonics, Inc. on May 6, 2016 and is designated Class II. Reason for recall: To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. The recall status is terminated (terminated April 18, 2017). Affected quantity: 2,345 units.

Recall Details

Product Type: Devices
Report Date: July 13, 2016
Initiation Date: May 6, 2016
Termination Date: April 18, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,345 units

Product Description

The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts.

Reason for Recall

To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice.

Distribution Pattern

Nationwide Distribution to IN, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO,MS, MT, NC, NE, NH, NJ, NM, NV, NY OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT,WA, WI, WV, and WY.

Code Information

All serial numbers