FDAFDA · Food and drugs·Recall number Z-0789-2022
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Published March 23, 2022 · Recall initiated: January 28, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sam Medical Products
- Distributor
- U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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