Class I U.S. Food and Drug Administration

Arrow International, LLC NextStep Antegrade Chronic Hemodialysis Catheter recall: 16F dual-valved splittable sheath introducer

Recall published 5 months ago

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2159-2026
Published
May 20, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Arrow International, LLC
Product type
Medical devices
Units affected
19,687
Distribution
Nationwide
Made in
United States
Lot / code info
REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283; CS-15422-SFX/30801902195327/33F23K0179, 33F23L0956, 33F24A0290, 33F24E0814; CS-15502-SFX/30801902195563/33F23L0959, 33F24A0286, 33F24J0060; CS-15192-SFXM/10801902127157/33F25C0015, 33F25E1084; CS-15232-SFXM/10801902127232/33F25C0671; AC-15192-X/ 00801902095879/33F23F0744, 33F24E0784, 33F25D0685; AC-15232-X/00801902095916/33F23H1013, 33F24J0068, 33F25C0675, 33F25J0589; AC-15272-X/00801902095954/33F23H1023; CS-15192-X/30801902195303/33F23C0886, 33F23E0564, 33F23G0263, 33F23G0533, 33F23K0712, 33F23L0935, 33F24E0187, 33F24E0793, 33F24G0171, 33F24J0017, 33F24J0041, 33F25D0701, 33F25E0476, 33F25F0486, 33F25H0783, 33F25H0857; CS-15232-X/30801902195556/33F23C0862, 33F23E0566, 33F23F0722, 33F23K0171, 33F23L0940, 33F24A0916, 33F24C0061, 33F24D1037, 33F24E0800, 33F24J0043, 33F24L0176, 33F25A0028, 33F25C0029, 33F25C0644, 33F25D0096, 33F25E0352, 33F25F0300, 33F25F0513, 33F25E0477, 33F25J0745; CS-15272-X/10801902195224/33F23C0887, 33F23F0731, 33F23H0983, 33F23K0190, 33F23L0947, 33F24E0807, 33F24F0124, 33F24J0018, 33F24J0050, 33F24L0054, 33F24L0063, 33F24M0006, 33F25C0684, 33F25E0342, 33F25F0276, 33F25J0641; CS-15312-X/30801902195310/33F23C0863, 33F23D0858, 33F23G0544; CS-15192-XM/10801902127225/33F25D0711; CS-15232-XM/10801902127300/33F25E0435; CS-15272-XM/10801902127409/33F25C0680, 33F25K0272; CS-15312-XM/10801902127508/33F25E0442
UPC codes
30801902197758, 00801902095909, 30801902195297, 30801902195549, 10801902195217, 30801902197529, 30801902195327, 30801902195563, 10801902127157, 10801902127232, 00801902095879, 00801902095916, 00801902095954, 30801902195303, 30801902195556, 10801902195224, 30801902195310, 10801902127225, 10801902127300, 10801902127409

Products covered by this recall

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Check your product

The notice names 37 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 30801902197758
  • 00801902095909
  • 30801902195297
  • 30801902195549
  • 10801902195217
  • 30801902197529
  • 30801902195327
  • 30801902195563
  • 10801902127157
  • 10801902127232
  • 00801902095879
  • 00801902095916
  • 00801902095954
  • 30801902195303
  • 30801902195556
  • 10801902195224
  • 30801902195310
  • 10801902127225
  • 10801902127300
  • 10801902127409

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • AC-15192-SFX
  • 30801902197758

Model or item number

On the rating label, the box or the instruction sheet.

  • AC-15192-SFX
  • AC-15232-SFX
  • CS-15192-SFX
  • CS-15232
  • CS-15192-SFXM
  • CS-15232-SFXM
  • AC-15192-X
  • AC-15232-X
  • AC-15272-X
  • CS-15192-X
  • CS
  • CS-15192-XM
  • CS-15232-XM
  • CS-15272-XM
  • CS-15312-XM

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Arrow International, LLC — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: ARROW INTERNATIONAL, LLC — 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Arrow International, LLC medical devices recalled?

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 30801902197758, 00801902095909, 30801902195297; lot code AC-15192-SFX, 30801902197758; model number AC-15192-SFX, AC-15232-SFX, CS-15192-SFX. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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