FDA (Devices) recall action 87407
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.
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
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.
Fenwal Inc is recalling 24 units of Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.
Fenwal Inc is recalling 2,466 Amicus Exchange Kits because centrifuge packs may leak blood during therapeutic procedures.
Fenwal Inc is recalling specific lots of Amicus MNC Apheresis Kits because centrifuge packs may leak blood during therapeutic procedures.