Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
AMD Medicom Inc.
The hazard
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. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UDI-DI: 10686864044465Model Lot: 17936UPC 10686864044465Would you have heard about this one?
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