FDA recall Z-0789-2022

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

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

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