FDA (Devices) recall action 97466
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
The Preventive Maintenance Kit ICEFX, batch 108159110, is recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. One unit is affected.
ICEfx Cryoablation Systems are recalled because certain desiccant tube subassemblies were built with end caps that were not correctly tightened. 18 units are affected.