Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Recalled by Sam Medical Products Due to Due to partially assembled valved dressing that has...

Date: January 28, 2022
Company: Sam Medical Products
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Sam Medical Products directly.

Affected Products

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

Quantity: 2,950 packages

Why Was This 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.

Where Was This Sold?

This product was distributed to 13 states: AZ, CA, CO, FL, GA, MA, NY, OR, PA, RI, TX, VA, WA

Affected (13 states)Not affected

About Sam Medical Products

Sam Medical Products has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report