Custom Assemblies recalled over sterility concerns

Recall date

October 28, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk

Recall number

Z-0400-2022

FDA classification

Class II

Brand / firm

Stradis Medical, LLC dba Stradis Healthcare

Sold / distributed

NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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