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Lower risk Medical device recall · FDA · Published September 21, 2018

Arrow AGB+ Multi-Lumen CVC Kit Recall: Labeling Inconsistencies

Arrow recalls AGB+ Multi-Lumen CVC Kits with inconsistent labeling of spring wire guide size. This may cause confusion in medical use but does not pose a safety risk.

🇺🇸 FDA recall #Z-0468-2019Medical deviceArrow ›
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Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

Arrow is recalling certain AGB+ Multi-Lumen CVC Kits due to inconsistent labeling of the spring wire guide size. This labeling error could lead to confusion during medical procedures but does not pose a safety risk to users. Read more at govinfonow.com/recall/69827-arrow-agb-multi-lumen-cvc-kit-recall-labeling-inconsistencies.

Source Summary by GovInfoNow · govinfonow.com/recall/69827-arrow-agb-multi-lumen-cvc-kit-recall-labeling-inconsistencies · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0468-2019

Cite this page

“Arrow AGB+ Multi-Lumen CVC Kit Recall: Labeling Inconsistencies.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69827-arrow-agb-multi-lumen-cvc-kit-recall-labeling-inconsistencies. Based on FDA recall #Z-0468-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0468-2019%22&limit=1).

The FDA announced on Sept. 21, 2018, that Arrow International Inc. is recalling its Arrow AGB+ Multi-Lumen CVC Kits due to labeling inconsistencies regarding the spring-wire guide size. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Arrow
  • Product: Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide
  • Product Code: CDC-45703-B1A
  • Lot Numbers: 13F17E0685, 13F17F0562, 13F17H0141, 13F17K0340, 13R17E0685
  • Quantity: 3640 units

The hazard

The products' labeling contains inconsistencies where the lidstock, banner card, or shipper label incorrectly states the Spring Wire Guide (SWG) size as .032 instead of the correct .025. The FDA noted these errors occur in certain instances across different lots.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Recent brand recalls include the July 26, 2024, Arrow Arterial Kits and Trays recall for open seals risk, the April 29, 2024, Arrow Ultra 8 IAB Catheter Kit recall for serious health consequences, and the Feb. 12, 2024, ARROW QuickFlash Radial Artery Catheter recall for arterial injury risk. Other recent recalls of similar products include the March 11, 2026, Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kit recall, the March 11, 2026, Arrow MAC Two-Lumen Central Venous Access Kit recall, and the March 11, 2026, Arrowg+ard Blue MAC Two-Lumen Catheter Kit recall, all for incorrect adhesive manufacturing.

How to tell if you have this one

Check the lot numbers: 13F17E0685, 13F17F0562, 13F17H0141, 13F17K0340, 13F18B0119, 13R17E0685. The product is an Arrow AGB+ Multi-Lumen CVC Kit with a 20cm catheter length and .025 inch diameter spring wire guide.

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

What to do — step by step

  1. Check Product Labeling

    Verify the spring wire guide size on the lidstock, banner card, and shipper label to ensure it matches the correct .025 inch size.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 9 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: named in the noticeIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Idaho, Illinois, Michigan, New Jersey, North Carolina, Pennsylvania, Wisconsin.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Sep 21, 201812. FDA classified it Class II: Nov 14, 201823. Published in FDA’s Enforcement Report: Nov 21, 201834. FDA terminated the recall: Sep 23, 2020420182020
  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.

✎ GovInfoNow

Questions people ask

Do I need to stop using the product?

No, the recall does not require stopping use; it is for labeling clarification only.

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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-0468-2019 (September 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0468-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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