Arrow International paracentesis kit recalled for contaminated anesthetic drugs
What this means
Arrow International included anesthetic drugs (lidocaine and bupivacaine) and saline solution from a supplier with quality problems into paracentesis kits. The supplier had reports of drug ineffectiveness, and if the sterility of these injectable products was compromised, patients could face serious injury.
- If you have kit ASK-00376-JHH (lots 33F25G0629 or 33F24K0592), do not use it.
- Contact Arrow International or your healthcare facility for instructions on replacement or safe disposal.
- Healthcare providers should quarantine affected kits and review patient records for any kits already used.
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-2386-2026Want us to check the next one for you?
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