Reported Mar 23, 2022 · Terminated
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Sam Medical Products
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sam Medical Products · 12200 SW Tualatin Rd Suite 200 · Tualatin, OR · 97062
Is this the product you have?
- SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
- Lot codes and dates
- Model NumberCS203-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 NumberY060321-09
- Amount recalled
- 2,950 packages
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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