Sam Medical Products recalls CS203-EN Combo chest seal lot Y060321-09 due to a hole in the dressing that prevents creating an occlusive seal over chest wounds. Affected units may not function correctly in emergencies.
Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered over the open chest wound and create an occlusive seal due to the hole being present.
Sam Medical Products is recalling chest seals with model CS203-EN that have a hole in the dressing. This hole prevents the seal from properly covering chest wounds, which could lead to life-threatening bleeding.
The dressing has a hole instead of being non-valved, so it cannot center over chest wounds. This means it won't create a proper seal, allowing air to enter and causing life-threatening bleeding.
Anyone who owns or uses the recalled chest seal model CS203-:EN Combo lot Y060321-09. Emergency responders and individuals with chest wounds are at highest risk.
Check for the model CS203-EN Combo with lot number Y060321-09 on the packaging. The product was sold in case cartons and individual pouches.
Immediately stop using the recalled chest seal as it cannot create a proper seal over chest wounds.
The dressing has a hole instead of being non-valved, so it cannot center over chest wounds and create an occlusive seal, risking life-threatening bleeding.
Check for model CS203-EN Combo with lot number Y060321-09 on the packaging, which was sold in case cartons and individual pouches.
Immediately stop using it now as it cannot create a proper seal over chest wounds.
We’ve drafted a message you can send Sam Medical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-0789-2022 — Sam Medical Products Sam Medical Products Hello, I own a Sam Medical Products that is covered by recall Z-0789-2022 from Sam Medical Products. 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.
