medical Class II Updated 2022-03-23

Sam Medical Products recalls SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Recalled Product

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, CA, CO, FL, GA, MA, NY, OR, PA, RI, TX, VA, WA
Lot/Code Info: Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)10822045000193(10)Y060321-09(17)270601 (Each Pouch/Package) Lot Number: Y060321-09
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