FDA (Devices) recall action 99006
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.
Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
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.
Ritmed Neurological Sponges are being recalled because they may not consistently meet the endotoxin specification for devices that contact cerebrospinal fluid. Ten units are affected.
Ritmed non-sterile Neurological Sponges across seven sizes are being recalled because they may not consistently meet the endotoxin specification for devices contacting cerebrospinal fluid.