FDAFDA · Food and drugs·Recall number Z-2381-2026
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Published June 24, 2026 · Recall initiated: April 21, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ARROW INTERNATIONAL, LLC
- Distributor
- US Nationwide distribution including in the states of VA, NY, UT, SC, LA, MN, PA, AZ, CA, MI, OH, FL, CT, KS, IL, TX, WI, GA, NC, MD, OR, AK, NH, IA, ND, OK, NM, AL, MA, KY, WA, AR, CO, IN, ME, TN, WY, NJ, SD, MS, MO, MT, DE, ID, NE, WV, RI, VT, NV, HI, DC, PR.
- Lot
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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