FDA (Devices) recall action 64177
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.
The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance.
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.
Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.
Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.