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Recall Observatory FDA recall evidence

Device product

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

Z-0789-2022

January 28, 2022

Class II

Product summary

Firm
Sam Medical Products
Event
Event 89510
Status
Terminated
Classification
Class II
Quantity
2,950 packages
Official record key
device-enforcement:Z-0789-2022

Official wording

Reason: 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.

Code information: 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

Distribution pattern: U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.