FDA-Device2021-12-29Class II
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Stradis Medical, LLC dba Stradis Healthcare
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.
Sold states
NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Affected count
620 tube sets
Manufactured in
3025 Northwoods Pkwy, N/A, Peachtree Corners, GA, United States
Products
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2022Don't want to check this manually?
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