Arrow International Pacing PSI Kits recalled for potential drug ineffectiveness and sterility compromise
What this means
Arrow International included local anesthetic drugs (lidocaine and bupivacaine) from a supplier with quality issues into several pacing procedure kits. The supplier's drugs had limited reports of ineffectiveness, and compromised sterility in injectable products could cause serious infection or other life-threatening complications.
- Check if your facility received any Pacing PSI Kits with the affected lot numbers listed in the recall notice.
- Do not use affected kits; quarantine them and contact Arrow International or the FDA if you have questions.
- Contact your hospital's pharmacy, procurement, or medical device team to verify whether your inventory is affected.
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-2366-2026Want us to check the next one for you?
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