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FDAMarch 10, 2020device

AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

What to do

FDA enforcement status: Terminated

Brands named

northgate technologiesnorthgate

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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