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FDAJanuary 28, 2022device

SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

sam medical productssamsam medical

UPCs

1082204500019010822045000193

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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