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

Medical DevicesSource: FDA (device) · Date: 2026-06-24

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
AMD Medicom Inc.
Product
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
Recall initiated
2026-05-08
Code info
UDI-DI: 10686864044465, Lot: 17936
Product quantity
10
Voluntary mandated
Voluntary: Firm initiated
City
Montreal
Country
Canada
Event id
99006
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