SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 — Class II medical device recall Z-0789-2022
Terminated recall by Sam Medical Products, reported 2022-03-23, distributed in AZ, CA, CO, FL, GA, MA, NY, OR…. Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressi
| Recall number | Z-0789-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sam Medical Products, Tualatin, OR, United States |
| Recall initiated | 2022-01-28 |
| Classified | 2022-03-16 |
| Reported by FDA | 2022-03-23 |
| Terminated | 2023-04-06 |
| Distributed | AZ, CA, CO, FL, GA, MA, NY, OR, PA, PR, RI, TX, VA, WA |
| Countries outside the US | CA |
| Quantity | 2,950 packages |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10822045000190 |
| Lot numbers | Y060321-09 |
| Model numbers | CS203-EN |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0789-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.