Sam Medical Products Recall 89510
Description: SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Sam Medical Products Recall 89510 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0789-2022 |
| Event ID | 89510 |
| Event Description | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 |
| Product Type | Devices |
| Distribution | U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada |
| Quantity | 2,950 packages |
| Recall 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. |
| Device Classification | 20220323 |
| Device 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 |
| Center Classification Date | 20220316 |
| Recall Initiation Date | 20220128 |
| Recalling Firm | Sam Medical Products |
| Initial Notification | Letter |
| Similar To |