United StatesRitmed Neurological Sponges — non‑sterile sizes 0.5x0.5in (REF 55992C), 0.5x1.0in (55993C), 0.5x3.0in (55994C), 0.75x0.75in (55995C), 1.0x1.0in (55996C), 1.0x3.0in (55997C), 0.5x1.5in (55998C), and a sterile 0.75x0.75in (REF 85995C) — distributed after May 1, 2022 in the listed lots, are being recalled by AMD Medicom Inc. They may not consistently meet endotoxin specifications for devices that contact cerebrospinal fluid and could cause neurovascular adverse events, febrile response, local transient inflammation, hypotension, or nausea.
What's being recalled
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
Recalling firm: AMD Medicom Inc., Montreal, Canada.
How to identify it
UDI-DI: 20686864043205. Distributed After May 1st, 2022, including the following lots: 19316, 16409, 15463-7, 15463-6, 15463-5, 15463-4, 15463-3, 15463-2, 15463-1, 15463, 15192-1, 15192, 14813, 14039, 13673, 13289, 12641, 12206, 11851, 11020-1, 11020, 10586, 10392, 9243, 8160, 7784, 7748, 7044 UDI-DI: 10686864044465, Lot: 17936
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US: MT, NC, VA, CA, TX, OH, TN, IL, RI
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada