SAM Chest Seal recall
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Why was SAM Chest Seal 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
- Recalling firm
- Sam Medical Products
- Quantity
- 2,950 packages
- Distribution
- U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
- Recall date
- March 23, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)