SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Check against the official notice below — it lists the full affected range.
Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL REF CS203-EN Combo from Lot Y060321-09 distributed across the United States (Arizona, California, Colorado, Florida, Georgia, Massachusetts, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Texas, Virginia, and Washington), Canada, and other locations. The recalled chest seals contain a partially assembled valved dressing with a hole instead of the intended non-valved dressing, which prevents the dressing from being centered properly over an open chest wound and creating an effective occlusive seal.
The defect means the dressing cannot function as intended to seal chest wounds. Consumers should identify affected products using the Lot Number Y060321-09 and Model Number CS203-EN. The recall record does not specify a remedy or what affected consumers should do with the recalled product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada Quantity: 2,950 packages Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.