Arrow Radial Artery Catheter Set Recall: Loose Foreign Matter Risk
Arrow recalls two radial artery catheter models due to potential loose polypropylene particles that could cause injury during use. Affected lot numbers: 23F16H0859 and 23F16J0547.
Lower-risk recall
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Contact the company
What happened, in plain English
Arrow is recalling two specific radial artery catheter models because they may contain loose polypropylene particles that could cause injury. This is a safety issue for medical professionals using these devices during procedures. Read more at govinfonow.com/recall/73445-arrow-radial-artery-catheter-set-recall-loose-foreign-matter-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73445-arrow-radial-artery-catheter-set-recall-loose-foreign-matter-risk · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0486-2018
Cite this page
“Arrow Radial Artery Catheter Set Recall: Loose Foreign Matter Risk.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73445-arrow-radial-artery-catheter-set-recall-loose-foreign-matter-risk. Based on FDA recall #Z-0486-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2018%22&limit=1).
Why it’s dangerous
The catheters may contain small pieces of polypropylene that could become dislodged during use. These particles might enter the bloodstream and cause complications like infection or blockages.
Who’s affected
Medical professionals who use these catheters for procedures are most at risk. Patients receiving these catheters during procedures could also be affected.
How to tell if you have this one
Check for lot numbers 23F16H0859 or 23F16J0547 on the packaging. The product names are Radial Artery Catheterization Set models NA-04550-1A and NA-04550-X1A.
- Brand
Arrow- Category
Medical device
What to do — step by step
Check Lot Numbers
Look for lot numbers 23F16H0859 or 23F16J0547 on the packaging.
How this recall unfolded
Recall timeline
FDA terminated this recall 14 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.
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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-0486-2018 (July 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0486-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 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.