medical Class II Updated 2020-05-13

Northgate Technologies, Inc. recalls Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product

Recalled Product

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.


Hazard / Issue

As part of an 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 9-900-54.
View official government recall

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