Tualatin, OR, United States
Sam Medical Products recalls
1 recall recorded since 2018, most recently on 28 January 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 28 January 2022
- Terminated
- 6 April 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0789-2022
- SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.