Arrow International Pacing PSI Kits recalled for potential drug ineffectiveness and sterility compromise
Arrow International Pacing PSI Kits recalled for sterility and drug concerns
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.
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-2366-2026More Arrow recalls
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