Sam Medical Products: Medical Device Recall in 2022 - (Recall #: Z-0789-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 28, 2022

Date Posted: March 23, 2022

Recall Number: Z-0789-2022

Event ID: 89510

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.

Status: Terminated

Product Quantity: 2,950 packages

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

Voluntary or Mandated:

Voluntary: Firm initiated