Centurion Neonatal IV Access Set Recall: Iodine Assay Issue

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Recalling firmCenturion Medical Products Corporation100 Centurion Way, N/A · Williamston, MI 48895-9086

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Centurion Medical is recalling neonatal IV access sets with certain lot codes because the PVP Prep Pad inside may not hold iodine levels needed for the full 36-month shelf life. This could affect the safety of the product over time.

Why it’s dangerous

The PVP Prep Pad in the Convenience Kit may not maintain sufficient iodine levels over time, which is critical for the product's shelf life. If iodine levels drop too low, the pad might not function properly during IV treatments, potentially causing issues for newborns.

Who’s affected

Healthcare providers using neonatal IV access sets with the listed lot codes are affected. Newborns receiving IV treatments are at the highest risk if the product fails.

How to tell if you have this one

Check the lot code on the IV access set packaging. The affected lot codes are 2015111690, 2016012590, 2016040490, 2016082990, 2016111490, 2017010990, 2017013090, 2017052990, and 2017080790.

Brand
Centurion Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Code
Look for the lot code on the IV access set packaging to determine if it is affected.

✎ GovInfoNow

Questions people ask

Why is this product being recalled?

The PVP Prep Pad in the Convenience Kit does not meet the iodine assay level required to support the 36-month shelf life.

What should I do if I have the affected lot codes?

Check the lot code on the packaging to see if it is listed; if affected, contact Centurion Medical for further instructions.

Is there a fix for this issue?

The recall record does not specify a remedy, so no immediate fix is provided.

Take action

Contact Centurion Medical

We’ve drafted a message you can send Centurion Medical to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1090-2018 — Centurion Medical Centurion Medical

Hello,

I own a Centurion Medical that is covered by recall Z-1090-2018 from Centurion Medical.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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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-1090-2018 (October 23, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1090-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 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.

Centurion Medical Products Corporation recalls NEONATAL IV ACCESS SET

Lower-risk recall