Recall Weekly
Serious riskFDA DeviceClass I

Arrow hemodialysis kit recalled for possible sterility risk

Arrow International hemodialysis kits contain anesthetic and saline solutions from a supplier with quality control problems and reports of drug ineffectiveness. If the sterility of these injectable products is compromised, patients could face serious or life-threatening complications.

From the FDA notice · Read the official notice ↗

What to do

  1. Check if your facility received hemodialysis kits with model AK-12122-F and any of the listed lot numbers
  2. Do not use affected kits; contact Arrow International or your distributor for replacement or instructions
  3. Report any adverse events to the FDA MedWatch program
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F
Sold in
Nationwide
Made for
Adults (18 years to 130 years)

This recall covers 35 products — see all of them.

Details

Units affected
1,945
Illnesses reported
None reported
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Classification
Class I
Recall number
Z-2381-2026

In the FDA's words

Description
Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-F 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. 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: 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. Affected quantity: 1,945
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.

35 products in this recall

Arrow kits with lidocaine and bupivacaine recalled for sterility risk

Arrow is recalling 35 kits and sets that contain lidocaine, bupivacaine, or 0.9% sodium chloride from a supplier that was itself recalled for quality issues. If the sterility of these water-based injectable drugs is compromised, it could lead to serious or life-threatening injuries. No injuries have been reported, and the products were distributed nationwide.

The agency lists each product separately. Check every one you might have.

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