Arrow International hemodialysis kit recalled for compromised sterility of anesthetic and saline components
Arrow International hemodialysis kit recalled for sterility issues
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.
- Check if your facility received hemodialysis kits with model AK-12122-F and any of the listed lot numbers
- Do not use affected kits; contact Arrow International or your distributor for replacement or instructions
- Report any adverse events to the FDA MedWatch program
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-2381-2026More 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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