FDA (Devices) recall action 85204
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
The agency’s own wording, quoted from the enforcement report.
Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.
Northgate Technologies is recalling ACMI 9FR probes used for stone fragmentation because a lot failed biocompatibility testing.
Northgate Technologies is recalling Autolith Uro-Tch 9FR probes because a lot failed biocompatibility testing. The recall covers 198 boxes distributed nationwide.