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Recall Observatory FDA recall evidence

Device product

Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Z-0400-2022

October 28, 2021

Class II

Product summary

Firm
Stradis Medical, LLC dba Stradis Healthcare
Event
Event 89046
Status
Terminated
Classification
Class II
Quantity
620 tube sets
Official record key
device-enforcement:Z-0400-2022

Official wording

Reason: 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.

Code information: Lot code 20519-2103

Distribution pattern: NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile