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FDA-Device2026-06-24Class IPROCESSING DEFECT

Arrow International spinal anesthesia kits recalled for potential sterility compromise

Arrow
Nationwide distribution

Arrow International spinal anesthesia kits recalled for sterility risk

Arrow International included injectable medications (lidocaine, bupivacaine, and sodium chloride) from a supplier with quality issues in multiple spinal anesthesia kits. The supplier's products may not be sterile or effective, which could cause serious injury during spinal procedures.

  • Check your facility's inventory against the affected lot numbers listed in the FDA notice
  • Do not use affected kits; quarantine them immediately
  • Contact Arrow International or your supplier for instructions on returning or replacing affected kits
  • Verify any spinal anesthesia kits used recently came from unaffected lots
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.

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
79,614
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB; SPINAL ANESTHESIA KIT/ASA-25090-SB; SPINAL ANESTHESIA KIT: 24 GA X 9 CM/ASK-24090-SA; SPINAL ANESTHESIA KIT: 25 GA X 9 CM/ASK-24090-SPH; SPINAL ANESTHESIA KIT/ASK-25090-BIDMC; SPINAL ANESTHESIA KIT/ASK-25090-UF

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2389-2026

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