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Lower risk Medical device recall · FDA · Published October 17, 2017

Angiodynamics Xcela PICC with PASV Valve: Mislabeled Size 4F vs 5F

Angiodynamics recalls Xcela PICC with PASV Valve Kit 5F-55cm due to mislabeling as 5F when it's actually 4F. This could lead to incorrect use in medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2617-2021Medical deviceAngiodynamics ›
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Contact the company

Recalling firmAngiodynamics Inc. (Navilyst Medical Inc.)10 Glens Falls Tech Park · Glens Falls, NY 12801-3864
✎ GovInfoNow plain-language explainer

Angiodynamics is recalling Xcela PICC lines with PASV Valve Technology that are mislabeled as 5F (55cm) when they are actually 4F. This mislabeling could lead to improper use in medical procedures if the wrong size is used. Read more at govinfonow.com/recall/72832-angiodynamics-xcela-picc-with-pasv-valve-mislabeled-size-4f-vs.

Source Summary by GovInfoNow · govinfonow.com/recall/72832-angiodynamics-xcela-picc-with-pasv-valve-mislabeled-size-4f-vs · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2617-2021

Cite this page

“Angiodynamics Xcela PICC with PASV Valve: Mislabeled Size 4F vs 5F.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72832-angiodynamics-xcela-picc-with-pasv-valve-mislabeled-size-4f-vs. Based on FDA recall #Z-2617-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2617-2021%22&limit=1).

The FDA announced on 2017-10-17 that Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Xcela PICC with PASV Valve Technology/Kit due to mislabeling hazards. The product labeled as 5F is actually 4F.

How to tell if you have it

  • Brand: Angiodynamics
  • Product: Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)
  • Catalog Number: 60M701995
  • Lot Number: 5210162
  • (UDI): H96560M7019951

The hazard

The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).

Context

GovInfoNow's records show Angiodynamics Inc. (Navilyst Medical Inc.) has 8 other recalls on record since 2018-01-18. Other recent recalls of similar products include Micro Therapeutics Pipeline Flex Embolization Device Recall: Incorrect Diameter Label (2026-06-25) and Micro Therapeutics Pipeline Flex Embolization Device: Incorrect Labeling Risk (2026-06-08).

How to tell if you have this one

Check the product label for the size designation (5F or 4F) and the catalog number (60M701995) and lot number (5210162). The UDI code is H96560M7019951.

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

What to do — step by step

  1. Check Product Label

    Look for the size designation (5F or 4F) and catalog number (60M701995) on the product label.

How this recall unfolded

Recall timeline

FDA terminated this recall 4.7 years after the firm started it.

1. Firm started the recall: Oct 17, 201712. FDA classified it Class II: Sep 30, 202123. Published in FDA’s Enforcement Report: Oct 6, 202134. FDA terminated the recall: Jun 14, 2022420172022
  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-2617-2021 (October 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2617-2021 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.
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