Drug recall
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
FDA recall event 89510 · Class II · Sam Medical Products
Key facts
| Event ID | 89510 |
|---|---|
| Recall numbers | Z-0789-2022 |
| Recalling firm | Sam Medical Products |
| Product type | Devices |
| Products | SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Jan 28, 2022 |
| Report date | Mar 23, 2022 |
| Termination date | Apr 6, 2023 |
| City | Tualatin |
| State | OR |
| Country | United States |
| FEI number | 3023316 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: