Arrow International spinal anesthesia kits recalled for potential sterility compromise
What this means
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
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-2389-2026Want us to check the next one for you?
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