Terumo Cardiovascular Kit Recall: Latex Not Declared on Label
Terumo recalls Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) due to natural rubber latex not being declared on label. Affected units have catalog number 140222 and lot numbers V A30.
Lower-risk recall
Presence of natural rubber latex is not declared in the label
Contact the company
What happened, in plain English
Terumo is recalling a cardiovascular procedure kit because it doesn't list natural rubber latex on its label. This could cause allergic reactions in people sensitive to latex, especially during medical procedures. Read more at govinfonow.com/recall/69300-terumo-cardiovascular-kit-recall-latex-not-declared-on-label.
Source Summary by GovInfoNow · govinfonow.com/recall/69300-terumo-cardiovascular-kit-recall-latex-not-declared-on-label · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0966-2019
Cite this page
“Terumo Cardiovascular Kit Recall: Latex Not Declared on Label.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69300-terumo-cardiovascular-kit-recall-latex-not-declared-on-label. Based on FDA recall #Z-0966-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2019%22&limit=1).
Why it’s dangerous
The kit contains natural rubber latex that isn't declared on the label. This could cause allergic reactions in sensitive individuals, especially during medical procedures where the kit is used.
Who’s affected
People who use this kit for medical procedures, particularly those with latex allergies. Healthcare workers and patients undergoing procedures are most at risk.
How to tell if you have this one
Check for catalog number 140222 and lot numbers V A30 on the kit packaging. The product is a cardiovascular procedure kit used in medical settings.
- Brand
Terumo- Category
Medical device
What to do — step by step
Check Label
Look for the catalog number 140222 and lot numbers V A30 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in Texas.
FDA distribution: “TX” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Texas.
Recall timeline
FDA terminated this recall 8 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.
Questions people ask
Is there a fix for this?
The recall is for labeling compliance; there is no repair or replacement offered. Affected users should check the label and contact Terumo if needed.
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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-0966-2019 (December 20, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0966-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.