Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.