Sam Medical Products recalls SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Recall date

January 28, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0789-2022

FDA classification

Class II

Brand / firm

Sam Medical Products

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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