AMD Medicom Inc.: Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C

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.

Details from the source

Reason for recall: 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. Distribution: US: MT, NC, VA, CA, TX, OH, TN, IL, RI Quantity: 10 Lot/code info: UDI-DI: 10686864044465, Lot: 17936

UPC codes

10686864044465

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.