Class I U.S. Food and Drug Administration

Arrow International, LLC Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP 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

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

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-2158-2026
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
34,568
Distribution
Nationwide
Made in
United States
Lot / code info
REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 33F23D0857, 33F23F0719, 33F23K0182, 33F24A0265, 33F24C0062, 33F24D1000, 33F24D1039, 33F24E0803, 33F24H0038, 33F24H0261, 33F24K0505, 33F24M0039, 33F24M0218, 33F25A0141, 33F25C0657, 33F25D0125, 33F25E0305, 33F25E0429, 33F25E0430, 33F25E1131, 33F25F0042, 33F25G0070, 33F25H0295, 33F25H0366, 33F25H0674, 33F25J1015; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062
UPC codes
30801902195273, 30801902195518, 20801902195184, 30801902195525, 30801902195198, 20801902096610, 20801902096634, 10801902193527, 10801902193688, 30801902193538, 20801902193548

Products covered by this recall

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Check your product

The notice names 24 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.

  • 30801902195273
  • 30801902195518
  • 20801902195184
  • 30801902195525
  • 30801902195198
  • 20801902096610
  • 20801902096634
  • 10801902193527
  • 10801902193688
  • 30801902193538
  • 20801902193548

Lot or batch code

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

  • CS-15242-VSP
  • 30801902195273
  • 33F23C0870
  • 33F23D0857
  • 33F23F0719
  • 33F23K0

Model or item number

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

  • CS-15242-VSP
  • CS-15282-VSP
  • CS-15322-VSP
  • CS-15362
  • CS-15242-SPM
  • CS-15282-SPM
  • CS-15322-SPM

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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

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 30801902195273, 30801902195518, 20801902195184; lot code CS-15242-VSP, 30801902195273, 33F23C0870; model number CS-15242-VSP, CS-15282-VSP, CS-15322-VSP. 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?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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