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Lower risk Medical device recall · FDA · Published May 2, 2019

Cook Neff Percutaneous Access Set Recall: Sterility Risk from Missing Packaging Seal

Cook recalls Neff Percutaneous Access Set (NPAS-10:00-RH-NT) due to potential missing bottom seal on packaging, risking unsterile use. Affected units sold with lot 8373482.

🇺🇸 FDA recall #Z-1780-2019Medical deviceCook ›
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Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cook is recalling a specific medical device because it might have been shipped without the bottom seal on its outer packaging. This could mean the product isn't sterile when used, which is dangerous for medical procedures. Read more at govinfonow.com/recall/67966-cook-neff-percutaneous-access-set-recall-sterility-risk-from-missing.

Source Summary by GovInfoNow · govinfonow.com/recall/67966-cook-neff-percutaneous-access-set-recall-sterility-risk-from-missing · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1780-2019

Cite this page

“Cook Neff Percutaneous Access Set Recall: Sterility Risk from Missing Packaging Seal.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/67966-cook-neff-percutaneous-access-set-recall-sterility-risk-from-missing. Based on FDA recall #Z-1780-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1780-2019%22&limit=1).

Why it’s dangerous

The device may have been manufactured without the bottom seal on the outer packaging. This could compromise the sterility of the product, making it unsafe for medical procedures.

Who’s affected

Healthcare professionals using the Neff Percutaneous Access Set for medical procedures are most at risk. Patients receiving this device could be affected if the product isn't sterile.

How to tell if you have this one

Check for the catalog number NPAS-100-RH-NT on the product. Affected units were sold with lot number 8373482.

  • Brand
    Cook
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Packaging

    Look for the catalog number NPAS-100-RH-NT and lot number 8373482 on the product packaging.

How this recall unfolded

Recall timeline

FDA terminated this recall 4 months after the firm started it.

1. Firm started the recall: May 2, 201912. FDA classified it Class II: Jun 13, 201923. Published in FDA’s Enforcement Report: Jun 19, 201934. FDA terminated the recall: Aug 23, 201942019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-1780-2019 (May 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1780-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA