medical Class II Updated 2020-05-13

Northgate Technologies, Inc. recalls AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-05

Recalled Product

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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: NTI Catalog Number 9-203-0543.
View official government recall

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