FDA (Devices) recall action 98045
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Potential for incomplete seal on header bag.
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.
AVID Medical is recalling 300 Halyard Midtown General Arteriogram trays over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 240 Halyard EP Lab packs over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 42 Halyard General Laparoscopy Packs over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 56 Halyard Head and Neck Trays over the potential for an incomplete seal on the header bag.
AVID Medical is recalling 90 Halyard Major Packs over the potential for an incomplete seal on the header bag.