Arrow International hemodialysis kit recalled for compromised sterility of anesthetic and saline components
What this means
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
The agency's original wording
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-2381-2026Want us to check the next one for you?
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