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Sam Medical Products recalls SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Recalled March 23, 2022 · FDA recall Z-0789-2022 · Sam Medical Products
Hazard
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. · FDA Class II
Units
2,950 packages
Sold at
U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
Description
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.
Product
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Manufacturer(s)
Sam Medical Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →