[pending] Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Pending LLM rewrite. Source: FDA_DEVICE Z-2459-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
- Manufacturer
- AMD Medicom Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 10686864044465
- Lot: 17936
Distribution
Distributed in 9 states:
- CA
- IL
- MT
- NC
- OH
- RI
- TN
- TX
- VA
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