# FDA recall Z-0400-2022

> **Stradis Medical, LLC dba Stradis Healthcare** · Class II · device recall initiated 2021-10-28.

## Product

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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0400-2022
- **Recalling firm:** Stradis Medical, LLC dba Stradis Healthcare
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-28
- **Report date:** 2021-12-29
- **Termination date:** 2023-08-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Peachtree Corners, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2022

## Citation

> AI Analytics. FDA recall Z-0400-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0400-2022. Source: US FDA. Licensed CC0.

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