Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Custom Assemblies Recalled by Stradis Medical, LLC dba Stradis Healthcare Due to This recall has been initiated to address bulk...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stradis Medical, LLC dba Stradis Healthcare directly.
Affected Products
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Quantity: 620 tube sets
Why Was This Recalled?
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
Where Was This Sold?
This product was distributed to 10 states: CO, CT, MA, MI, NJ, NY, NC, OH, OR, TX
About Stradis Medical, LLC dba Stradis Healthcare
Stradis Medical, LLC dba Stradis Healthcare has 93 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report