Arrow International hemodialysis kits recalled for compromised sterility and drug ineffectiveness
Arrow International hemodialysis kits recalled for sterility issues
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.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2372-2026More Arrow recalls
- FDA-Device2026-06-24Arrow International hemodialysis kits recalled for contaminated anesthetic and saline solutions
- FDA-Device2026-06-24Arrow International PI CVC kits recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International PICC kits and stylets recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International PICC and JACC catheter kits recalled for contaminated anesthetic and saline components
- FDA-Device2026-06-24Arrow International Pacing PSI Kits recalled for potential drug ineffectiveness and sterility compromise
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