The Recall Desk
SevereFDA (Devices)·Z-2381-2026·Announced 2026-06-24

Arrow 12 Fr hemodialysis kit contains drugs from a recalled supplier

The Arrow two-lumen 12 Fr x 16 cm hemodialysis kit is being recalled because it contains lidocaine, bupivacaine and 0.9% sodium chloride subject to a supplier recall. 1,945 units affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no death is reported in the source, so it does not escalate to Critical.

Plain-English summary

Arrow International is recalling the two-lumen hemodialysis kit, 12 Fr x 16 cm, REF AK-12122-F. The action covers 1,945 units.

Lidocaine, bupivacaine and 0.9% sodium chloride, the subject of a supplier recall, were included in the kits and sets. According to the manufacturer, the supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States across a large number of states. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF, UDI-DI codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by Arrow International.

The recalled product

Product
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Manufacturer
ARROW INTERNATIONAL, LLC
Category
Medical Device — Hemodialysis catheter kit
Hazard
Affected units
1,945

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • REF(Material)/UDI-DI/Lot(Batch): AK-12122-F/10801902197129
  • 10801902193275
  • 10801902197129
  • 10801902168464/33F24B0184
  • 33F24D0076
  • 33F24F0321
  • 33F24G0345
  • 33F24K0111
  • 33F25A0474
  • 33F25C0915
  • 33F25E0061
  • 33F25E0924
  • 33F25J0832
  • 33F25L0404
  • 33F26B0552
  • 33F24A0102

Distribution

Distributed nationwide across the United States.

The notice also names 52 states specifically:

Part of a larger recall action

This product is one of 35 recalled by ARROW INTERNATIONAL, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 35 products in this recall →

Related recalls

Same manufacturer · ARROW INTERNATIONAL, LLC

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Same hazard · contained drug recall

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