Stradis Healthcare: Custom Assemblies Single Spike Tumescent Set Recall - Non-sterile Risk
Stradis Healthcare recalls bulk non-sterile Custom Assemblies Single Spike Tumescent Set (Reorder CMS-1212NS) due to incorrect distribution. This poses infection risk if used for sterile procedures.
Lower-risk 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.
Contact the company
What happened, in plain English
Stradis Healthcare is recalling bulk packs of Custom Assemblies Single Spike Tumescent Set (Reorder CMS-1212NS) because they were mistakenly distributed as non-sterile when sterile versions were ordered. Using these sets for sterile medical procedures could lead to infections. Read more at govinfonow.com/recall/61621-stradis-healthcare-custom-assemblies-single-spike-tumescent-set-recall-non.
Source Summary by GovInfoNow · govinfonow.com/recall/61621-stradis-healthcare-custom-assemblies-single-spike-tumescent-set-recall-non · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0400-2022
Cite this page
“Stradis Healthcare: Custom Assemblies Single Spike Tumescent Set Recall - Non-sterile Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61621-stradis-healthcare-custom-assemblies-single-spike-tumescent-set-recall-non. Based on FDA recall #Z-0400-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0400-2022%22&limit=1).
Why it’s dangerous
The sets were distributed without proper sterilization, meaning they could carry contaminants. When used for sterile medical procedures, this increases infection risk for patients and staff.
Who’s affected
Healthcare professionals who ordered this specific bulk set for sterile procedures may be affected. Patients receiving procedures using these sets face infection risks.
How to tell if you have this one
Check for the Reorder Number CMS-1212NS on the product label. The bulk set was sold with Lot code 20519-2103.
- Brand
Stradis Healthcare- Category
Medical device
What to do — step by step
Check Product Label
Look for the Reorder Number CMS-1212NS and Lot code 20519-2103 on the set.
Where it went and when
Where it was distributed
Distributed in 10 states.
FDA distribution: “NJ, MI, MA, NY, TX, CO, NC, CT, OR, OH” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Colorado, Connecticut, Massachusetts, Michigan, New Jersey, New York, North Carolina, Ohio, Oregon, Texas.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0400-2022 (October 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0400-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.