FDA (Devices) recall action 98913
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.
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
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.
Medtronic 2x4 Pocket Adaptor Kits for Deep Brain Stimulation, model 64002, are being recalled because a limited number are labeled with incorrect use-by dates.
Medtronic 1x4 Pocket Adaptor Kits for Deep Brain Stimulation, model 64001, are being recalled because a limited number are labeled with incorrect use-by dates. 275 units are affected.