FDA (Devices) recall action 91704
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.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
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 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.
Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.