FDA-Device2022-03-23Class II
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
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.
Sold states
U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
Affected count
2,950 packages
Manufactured in
12200 SW Tualatin Rd Suite 200, N/A, Tualatin, OR, United States
Products
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0789-2022Don't want to check this manually?
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