FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International hemodialysis kits recalled for compromised sterility and drug ineffectiveness

Nationwide distributionMedical devices

What this means

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality problems into hemodialysis kits. The supplier's products may not be sterile or effective, which could cause serious injury if used.

If you received or used one of these kits (lot numbers 36F25E0021 or 33F25B0467), contact Arrow International or your healthcare provider immediately.
Do not use affected kits. Affected units were distributed nationwide.

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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 count

1180

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2372-2026

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