Stradis Medical, LLC dba Stradis Healthcare Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Brand
Stradis Medical, LLC dba Stradis Healthcare
Lot Codes / Batch Numbers
Lot code 20519-2103
Products Sold
Lot code 20519-2103
Stradis Medical, LLC dba Stradis Healthcare is recalling Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk due to This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Stradis Healthcare immediately contacted all 28 customers via email and/or phone between 10/28/21 and 10/29/21. The firm has requested the return of the units.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, CT, MA, MI, NJ, NY, NC, OH, OR, TX
Page updated: Jan 10, 2026