Arrow International pacing/PSI kit recalled for compromised sterility of injectable anesthetics
What this means
Arrow International included lidocaine, bupivacaine, and saline solution from a supplier with quality issues in pacing/PSI kits. The supplier's products had limited reports of drug ineffectiveness, and if the sterility of these injectable products is compromised, it could cause serious or life-threatening injury. Approximately 95 kits were distributed nationwide.
- If you have an affected kit (model ASK-07155-MGU, lot 33F25C0798), do not use it.
- Contact your healthcare provider or Arrow International for guidance on replacement or proper disposal.
- Report any adverse events or product issues 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-2383-2026Want us to check the next one for you?
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