---
title: "Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Numb... — FDA record Z-0400-2022 | Is It on Recall"
description: "This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the st"
url: https://isitonrecall.com/recall/fda-device-z-0400-2022-custom-assemblies-inc-single-spike-tumescent-set-w-o-chamber-reorder-number-cms-1212ns-bulk/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk — FDA record Z-0400-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 28, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
- **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.
- **Classification**: Class II
- **Recalling firm**: Stradis Medical, LLC dba Stradis Healthcare
- **Quantity**: 620 tube sets
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0400-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0400-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Lot code 20519-2103 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Colorado](https://isitonrecall.com/state/colorado/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Dec 29, 2021
- **Recall initiation date**: Oct 28, 2021
- **Center classification date**: Dec 20, 2021
- **Termination date**: Aug 7, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0400-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Stradis Medical, LLC dba Stradis Healthcare records](https://isitonrecall.com/brand/stradis-medical-llc-dba-stradis-healthcare/)