Lower risk Medical device recall · FDA · Published December 12, 2019

Arrow Arterial Catheter Kit: Incorrect MRI Safety Label Risk

Arrow recalls arterial catheter kits with incorrect MRI safety labeling. The kit may be unsafe for MRI scans due to mislabeled magnetic resonance compatibility.

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

🇺🇸 FDA recall #Z-0844-2020Medical device Arrow ›

Lower-risk recall

The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit

Take action

Contact the company

Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607

✎ GovInfoNow plain-language explainer

Arrow is recalling arterial catheter kits that have a label error showing an MRI-safe symbol instead of MRI-unsafe. This could lead to dangerous MRI scans if the kit is used incorrectly. Read more at govinfonow.com/recall/66329-arrow-arterial-catheter-kit-incorrect-mri-safety-label-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66329-arrow-arterial-catheter-kit-incorrect-mri-safety-label-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0844-2020

Cite this page

“Arrow Arterial Catheter Kit: Incorrect MRI Safety Label Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66329-arrow-arterial-catheter-kit-incorrect-mri-safety-label-risk. Based on FDA recall #Z-0844-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0844-2020%22&limit=1).

The FDA announced on 2019-12-12 that Arrow International Inc. voluntarily recalled its Arrow Arterial Catheterization Kit due to a labeling error displaying an incorrect Magnetic Resonance symbol, according to the FDA.

How to tell if you have it

Brand: Arrow
Product: Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide
Product Code: ASK-04020-PMC
Lot/Batch Number: PMC 23F19H0224
Quantity: 80 eaches

The hazard

The lidstock label incorrectly displays a MR (Magnetic Resonance) Conditional symbol instead of a MR Unsafe symbol in reference to a component of the kit, according to the FDA.

Context

GovInfoNow's records show ARROW INTERNATIONAL Inc. has 52 other recalls on record since 2017-06-01. Other recent recalls include Arrow Arterial Kits and Trays (2024-07-26), the Arrow UltraFlex Intra-Aortic Balloon Catheter Kit (2024-04-29), and the ARROW QuickFlash Radial Artery Catheter (2024-02-12). Additional similar product recalls include the Arrow Radial Artery Catheter Kit (2026-03-11), Arrow PI Midline 2L Catheter (2026-04-21), and Arrow Arterial Line Kits (2026-04-21).

How to tell if you have this one

Check for the product code ASK-040:20-PMC on the kit. The kit was sold with lot/batch number PMC 23F19H0224.

Brand
Arrow
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Label
Verify the label shows the correct MRI unsafe symbol (not the MR safe symbol) for the kit.

Where it went and when

Where it was distributed

Distributed in South Carolina.

FDA distribution: “US distribution to SC” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: South Carolina.

Recall timeline

FDA published this recall 48 days after the firm started it.

Dec 12, 2019Firm started the recall
Jan 23, 2020FDA classified it Class II
Jan 29, 2020Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Arrow recalls

Link to this recall

<a href="https://govinfonow.com/recall/66329-arrow-arterial-catheter-kit-incorrect-mri-safety-label-risk">Arrow Arterial Catheter Kit: Incorrect MRI Safety Label Risk (GovInfoNow)</a>

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-0844-2020 (December 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0844-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.