Vygon IV Start Kits Recall: Iodine Prep Pads May Not Meet Expiration Standards
Vygon IV Start Convenience Kits with product codes AMS-623T and AMS-626TGSLF are recalled due to iodine prep pads not meeting 36-month expiration requirements. Affected kits may not be safe for IV use.
Lower-risk recall
The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.
Contact the company
What happened, in plain English
Vygon IV Start Convenience Kits with specific product codes are being recalled because the iodine prep pads inside may not meet the required iodine levels to stay safe for 36 months. This could mean the pads become ineffective or unsafe during IV procedures. Read more at govinfonow.com/recall/72913-vygon-iv-start-kits-recall-iodine-prep-pads-may-not.
Source Summary by GovInfoNow · govinfonow.com/recall/72913-vygon-iv-start-kits-recall-iodine-prep-pads-may-not · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0933-2018
Cite this page
“Vygon IV Start Kits Recall: Iodine Prep Pads May Not Meet Expiration Standards.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72913-vygon-iv-start-kits-recall-iodine-prep-pads-may-not. Based on FDA recall #Z-0933-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0933-2018%22&limit=1).
Why it’s dangerous
The iodine prep pads in the kits may not have enough iodine to meet the required levels for the full 36-month expiration date. This could lead to the pads becoming ineffective during IV procedures, potentially causing issues with infection control or treatment.
Who’s affected
Healthcare professionals using these kits for IV administration during emergencies are most likely affected. Patients receiving IV treatments with recalled kits could be at risk if the iodine pads fail.
How to tell if you have this one
Check for product codes AMS-623T (with specific serial numbers) or AMS-626TGSLF in the Vygon IV Start Convenience Kits. These kits are used for emergency IV administration.
- Brand
Churchill Medical Systems- Category
Medical device
What to do — step by step
Check Product Codes
Identify kits with product codes AMS-623T or AMS-626TGSLF to confirm if they are affected.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.3 years 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
Are there any risks to patients using these kits?
The recall is due to potential issues with the iodine pads, which could affect the safety of IV procedures, but the risk is considered low as the kits are not expected to cause serious harm.
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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-0933-2018 (October 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0933-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 17, 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.