SAM CHEST SEAL devices recalled due to assembly defect preventing wound seal
Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL (Model CS203-EN, Lot Y060321-09) with defective dressing containing holes that prevent creating an occlusive seal for chest wounds.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a manufacturing defect that prevents its intended critical function—creating an occlusive seal on chest wounds. While no injuries or hospitalizations have been reported in the recall notice, this is a risk-of-harm product where the defect could prevent proper emergency treatment.
Plain-English summary
Sam Medical Products is recalling 2,950 packages of SAM CHEST SEAL REF CS203-EN Combo with Lot Number Y060321-09. The product is a medical device designed to create an occlusive seal over open chest wounds.
The affected devices contain a manufacturing defect: instead of the intended non-valved dressing, some packages contain a partially assembled valved dressing with a hole in it. This defect prevents the dressing from being centered properly over an open chest wound and prevents the creation of an occlusive (airtight) seal.
The recalled devices were distributed in the United States (Arizona, California, Colorado, Florida, Georgia, Massachusetts, New York, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Texas, Virginia, and Washington) and Canada.
Healthcare providers and patients who have this product should stop using affected packages immediately. Verify the product lot number (Y060321-09) before use and contact Sam Medical Products or use an alternative chest seal product if needed.
The recalled product
- Product
- SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
- Manufacturer
- Sam Medical Products
- Affected units
- 2,950
Distribution
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