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Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Recalled December 29, 2021 · FDA recall Z-0400-2022 · Stradis Medical, LLC
Hazard
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. · FDA Class II
Units
620 tube sets
Sold at
NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Description
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.
Product
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Manufacturer(s)
Stradis Medical, LLC dba Stradis Healthcare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →