SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
Reported: March 23, 2022 Initiated: January 28, 2022 #Z-0789-2022
Product Description
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09
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.
Details
- Recalling Firm
- Sam Medical Products
- Units Affected
- 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
- Location
- Tualatin, OR
Frequently Asked Questions
What product was recalled? ▼
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09. Recalled by Sam Medical Products. Units affected: 2,950 packages.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2022. Severity: Moderate. Recall number: Z-0789-2022.
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