FDA (Devices) recall action 98060
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.
Devices are not suitable for organ transplant.
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 380 Halyard Mini Plus Kit South units because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
AVID Medical is recalling 52 Halyard Organ Recovery OR Packs because the devices are not suitable for organ transplant. The FDA has classified the action as Class I.
AVID Medical is recalling 132 Halyard Organ Recovery OR Packs, kit code LLOG1000-15, because the devices are not suitable for organ transplant.