Recall of specific medical procedure kits due to potential for unexpected endotoxin levels in Ritmed Neurological Sponges. Affected items include CRANI PACK, SPINE PACK, and other surgical trays with listed model numbers and lot numbers.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
American Contract Systems is recalling specific medical procedure kits and trays that contain Ritmed Neurological Sponges. The recall is due to potential for unexpected variability in endotoxin levels, which could pose a risk during medical procedures.
The Ritmed Neurological Sponges in these kits may have unexpected variations in endotoxin levels. Endotoxins are bacterial components that can cause infections or adverse reactions if introduced into the body during medical procedures.
Healthcare professionals and medical facilities that use these specific kits and trays are most at risk. The recall affects only the listed model numbers and lot numbers.
Check for the model numbers and lot numbers listed in the recall notice: CRANI PACK (UDCP57AI), SPINE PACK (HSLM53AC), CRANIAL PACK (MHCP75AH), and other specific kits with the listed UDI/DI and lot numbers.
Identify if your kit has the model numbers and lot numbers listed in the recall notice.
The recall is due to potential for unexpected variability in endotoxin levels in Ritmed Neurological Sponges, which could pose a risk during medical procedures.
The affected products include CRANI PACK (UDCP57AI), SPINE PACK (HSLM53AC), CRANIAL PACK (MHCP75AH), and other kits with the listed model numbers and lot numbers.
No immediate stop is required; the recall is for products with specific model numbers and lot numbers, and the risk is low.
We’ve drafted a message you can send American Contract Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-2989-2026 — American Contract Systems American Contract Systems Hello, I own a American Contract Systems that is covered by recall Z-2989-2026 from American Contract Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
