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Terminated

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.

FDA Recall Z-2130-2016 · Posted 2016-07-06

Recalling FirmCustom Ultrasonics, Inc.
Recall StatusTerminated
Product CodeNVE
Date Initiated2016-05-06
Date Terminated2017-04-18
Product Quantity2,345 units

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.

Firm Action

Custom Ultrasonics, Inc. sent an Urgent Medical Device Recall letter dated May 6, 2016, to all affected customers. The letter advised customers not to use the System 83 Plus AERs for cleaning and/or high-level disinfection of duodenoscopes until further notice. In addition, they sent a warning label for customers to affix in a prominent location on the System 83 Plus AER's on or before June 3, 2016 stating the following: "This device is not indicated for reprocessing of duodenoscopes. Do not reprocess any duodenoscopes in this device until further notice. For alternative reprocessing options, please contact the duodenoscope manufacturer." For questions regarding this recall call 215-364-1477.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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