Home / Recalls / Sam Medical Products / Z-0789-2022

Z-0789-2022 Class II Terminated

Recalled by Sam Medical Products — Tualatin, OR

Recall Details

Product Type: Devices
Report Date: March 23, 2022
Initiation Date: January 28, 2022
Termination Date: April 6, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,950 packages

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

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