Sam Medical Products 2022-03-23 Health serious FDA
Health · FDA · Recall #FDA-Z-0789-2022
SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 Recall
Issued March 23, 2022 · Sam Medical Products
In March 2022, Sam Medical Products recalled the SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using SAM CHEST SEAL REF CS203-EN Combo LOT Y060321-09 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Sam Medical Products to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Sam Medical Products
- Category
- Health
- Recall date
- March 23, 2022
- Units affected
- Not reported
- Sold at
- U.S.: AZ, CA, CO, FL, GA, MA, NY, OR, PA, Puerto Rico, RI, TX, VA, and WA O.U.S.: Canada
- Recall number
- FDA-Z-0789-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- Sam Medical Products has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.