Class II U.S. Food and Drug Administration

Arrow International, LLC MAC" Two-Lumen Central Venous Access Kit for use with 7.5 recall: Due to receiving a notice from a supplier that the liquid adhesive

Recall published 6 months ago

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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: Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

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-1916-2026
Published
April 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Arrow International, LLC
Product type
Medical devices
Units affected
90
Distribution
Nationwide
Made in
United States
Lot / code info
Product Code: ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 Batch Number: 33F25M0670
UPC codes
10801902206807

Products covered by this recall

MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ASK-11142-LC2 UDI code: (01)10801902206807(17)270531(11)251211(10)33F25M0670 The MAC Multi-Lumen Central Venous Access Device permits short-term (<30 days) venous access and catheter introduction to the central circulation.

Check your product

The notice names 2 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.

  • 10801902206807

Lot or batch code

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

  • 33F25M0670 — 90

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. 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.

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?

Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10801902206807; lot code 33F25M0670 — 90. 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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