Stradis Medical, LLC dba Stradis Healthcare: Medical Device Recall in 2021 - (Recall #: Z-0400-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 28, 2021

Date Posted: December 29, 2021

Recall Number: Z-0400-2022

Event ID: 89046

Reason for Recall:

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.

Status: Terminated

Product Quantity: 620 tube sets

Code Information:

Lot code 20519-2103

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated