Reported Jun 24, 2026 · Ongoing
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Arrow International, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARROW INTERNATIONAL, LLC · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
- Description/REFHEMODIALYSIS
- KIT2-LUMEN 12 FR X 16 CM/AK-12122-F
- Lot codes and dates
- REF(Material)/UDI-DI/Lot(Batch)
AK-12122-F/10801902197129108019021932751080190219712910801902168464/33F24B018433F24D007633F24F032133F24G034533F24K011133F25A047433F25C091533F25E006133F25E092433F25J083233F25L040433F26B055233F24A0102
- REF(Material)/UDI-DI/Lot(Batch)
- Amount recalled
- 1,945
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
Why it was recalled
Stop using this product now
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. 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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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