483
Richard Wolf Medical Instruments Corp.Richard Wolf Medical Instruments Corp. – FDA 483, Mar 18, 2020
Record Details
Richard Wolf Medical Instruments Corp. in Vernon Hills, IL, received a Form FDA 483 for failing to submit a Medical Device Report (MDR) within the required 30-day timeframe. The firm became aware of a malfunctioning insufflator and TEM pump that delayed a surgery in August 2018 but did not report it to the FDA until March 2019. This indicates a significant delay in reporting a device malfunction that could contribute to serious injury if it were to recur.
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- Chicago District Office
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ID · 029b2b66-9035-456e-8ae2-49920e5337b7
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