# FDA recall Z-0789-2022

> **Sam Medical Products** · Class II · device recall initiated 2022-01-28.

## Product

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

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

## Key facts

- **Recall number:** Z-0789-2022
- **Recalling firm:** Sam Medical Products
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-28
- **Report date:** 2022-03-23
- **Termination date:** 2023-04-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tualatin, OR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0789-2022

## Citation

> AI Analytics. FDA recall Z-0789-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0789-2022. Source: US FDA. Licensed CC0.

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