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Lower risk Medical device recall · FDA · Published October 26, 2017

Arrow Radial Artery Catheter Kit: Povidone Iodine Pads Expire in 24 Months

Arrow recalls Radial Artery Catheterization Kit model AK-04220 with povidone iodine prep pads that expire after 24 months instead of 36. Affected kits have specific lot numbers and expiration dates.

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

🇺🇸 FDA recall #Z-1286-2018Medical deviceArrow ›
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Contact the company

Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
✎ GovInfoNow plain-language explainer

Arrow is recalling certain Radial Artery Catheterization Kits (model AK-04220) because the included povidone iodine prep pads expire after 24 months, not the standard 36 months. This could lead to ineffective disinfection if used past their expiration date. Read more at govinfonow.com/recall/72654-arrow-radial-artery-catheter-kit-povidone-iodine-pads-expire-in.

Source Summary by GovInfoNow · govinfonow.com/recall/72654-arrow-radial-artery-catheter-kit-povidone-iodine-pads-expire-in · Updated September 14, 2026 · FDA enforcement record: FDA #Z-1286-2018

Cite this page

“Arrow Radial Artery Catheter Kit: Povidone Iodine Pads Expire in 24 Months.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72654-arrow-radial-artery-catheter-kit-povidone-iodine-pads-expire-in. Based on FDA recall #Z-1286-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1286-2018%22&limit=1).

The FDA announced on Oct. 26, 2017, that Arrow International Inc. is recalling Radial Artery Catheterization Kits because the included povidone iodine prep pads do not meet 36-month shelf-life requirements. The agency said owners should contact the company for a replacement.

How to tell if you have it

  • Brand: Arrow
  • Product: Radial Artery Catheterization Kit
  • Model: AK-04220
  • Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018
  • Expiration dates: October 2018 through March 2020

The hazard

The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life, according to the FDA.

Context

GovInfoNow's records show Arrow International Inc. has 52 other recalls on record since June 1, 2017. Other recent recalls of similar products include ARROW Arterial Kits and Trays (July 26, 2024), Arrow UltraFlex Intra-Aortic Balloon Catheter Kit Recall (April 29, 2024), and ARROW QuickFlash Radial Artery Catheter Recall (Feb. 12, 2024). Other recent recalls of similar products include ARROW Recalls Arterial Catheter Kits with Risk of Serious Injury from Contaminated Drugs (April 21, 2026), Arrow Recalls Catheter Kits with Possible Drug Contamination Risk (April 21, 2026), and Covidien EndoFLIP System: Catheters May Be Incorrectly Flagged as Expired (May 13, 2026).

How to tell if you have this one

Check for the model number AK-04220 on the kit. Look for lot numbers: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, or 23F16J0018. The expiration dates range from October 2018 to March 2020.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 7 products

All 7 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    US nationwide distribution, including Puerto Rico.
Recall numberProduct, codes & lotsQuantity
Z-1281-2018Radial Artery Catheterization Kit; Model: AK-04018; Lots: 13F16H0183, 13F17E0728, 13F17F0525, 23F16E1188, 23F16H0911; Expiration dates: October 2018 through March 2020930
Z-1282-2018Radial Artery Catheterization Kit; Model: AK-04020; Lots: 13F16H0263, 13F16J0335, 13F16K0145, 13F16M0246, 13F17C0500, 13F17F0199, 13F17F0473, 13F17F0530, 13F17G0325, 23F16E1189, 23F16E1190, 23F16F0474, 23F16F1041, 23F16H0164; Expiration dates: October 2018 through March 202050,263
Z-1283-2018Radial Artery Catheterization Kit; Model: AK-04020-C; Lots: 13F16H0430, 13F16M0224, 13F16M0242, 13F17F0150, 13F17F0475, 13F17G0240, 23F16E1193, 23F16F0476, 23F16G0085, 23F16H0013, 23F16H0680; Expiration dates: October 2018 through March 202024,192
Z-1284-2018Radial Artery Catheterization Kit; Model: AK-04120; Lots: 13F16H0289, 13F16M0161, 13F17E0858, 13F17G0178, 23F16E1191, 23F16H0163; Expiration dates: October 2018 through March 20202491
Z-1285-2018Radial Artery Catheterization Kit; Model: AK-04122; Lots: 13F16H0329, 13F17F0074, 13F17G0237; Expiration dates: October 2018 through March 2020570
Z-1286-2018Radial Artery Catheterization Kit; Model: AK-04220; Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 20206358
Z-1287-2018Arterial Access Tray, introducer catheter; Model: GU-04020; Lots: 13F17A0292, 13F17C0309, 13F17E0359, 13F17G0300, 13F17J0242, 23F16F0623, 23F16G0675; Expiration dates: October 2018 through March 20201190
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Expiration

    Verify the expiration date on the povidone iodine prep pads; they should not be past their 24-month expiration date.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFLPuerto Rico: yesPR

FDA distribution: “US nationwide distribution, including Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.1 years after the firm started it.

1. Firm started the recall: Oct 26, 201712. FDA classified it Class II: Apr 2, 201823. Published in FDA’s Enforcement Report: Apr 11, 201834. FDA terminated the recall: Dec 10, 2019420172019
  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-1286-2018 (October 26, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1286-2018 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