medical Class II Updated 2021-12-29

Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Cham

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH
Lot/Code Info: Lot code 20519-2103
View official government recall

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