Recall archive / FDA device enforcement
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 — FDA record Z-0789-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 28, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
- 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.
- Classification
- Class II
- Recalling firm
- Sam Medical Products
- Quantity
- 2,950 packages
- Agency-reported status
- Terminated
- Source record identifier
- Z-0789-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: CS203-EN UDI Code: (01)10822045000190(10)Y060321-09(17)270601 (Case Carton) UDI Code: (01)10822045000193(10)Y060321-09(17)270601 (Each Pouch/Package) Lot Number: Y060321-09 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 23, 2022
- Recall initiation date
- Jan 28, 2022
- Center classification date
- Mar 16, 2022
- Termination date
- Apr 6, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.