Product Safety Recalls

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Sam Medical Products Recall 89510

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

Sam Medical Products Recall 89510 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0789-2022
Event ID89510
Event DescriptionSAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Product TypeDevices
DistributionU.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
Quantity2,950 packages
Recall ReasonDue 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.
Device Classification20220323
Device Code InfoModel 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
Center Classification Date20220316
Recall Initiation Date20220128
Recalling FirmSam Medical Products
Initial Notification Letter
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