483
Thrombolex IncFDA 483 - Thrombolex Inc - March 30, 2023
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Record Details
Thrombolex Inc, a medical device manufacturer in New Britain, PA, was inspected by the FDA from March 29-30, 2023. The inspection revealed one significant observation regarding the firm's failure to submit a Medical Device Report (MDR) for a device malfunction. This malfunction, involving a broken guidewire port on their BASHIR Endovascular Catheter Plus, was likely to cause or contribute to a serious injury if it were to recur.
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ID · 4d69896a-f2a9-41c3-bb33-d43d7e1df39c