Custom Assemblies — Class II medical device recall Z-0400-2022
Terminated recall by Stradis Medical, LLC dba Stradis Healthcare, reported 2021-12-29, distributed in CO, CT, MA, MI, NC, NJ, NY, OH…. This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were
| Recall number | Z-0400-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stradis Medical, LLC dba Stradis Healthcare, Peachtree Corners, GA, United States |
| Recall initiated | 2021-10-28 |
| Classified | 2021-12-20 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2023-08-07 |
| Distributed | CO, CT, MA, MI, NC, NJ, NY, OH, OR, TX |
| Quantity | 620 tubes |
| Reason classes | sterility |
| Lot numbers | 20519-2103 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0400-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.