Arrow International paracentesis kits recalled for compromised sterility and drug ineffectiveness
What this means
Arrow International paracentesis kits (models AK-00376 and ASK-00376-VCU) contain anesthetic and saline solutions from a supplier with quality issues and reports of drug ineffectiveness. If the sterility of these injectable products is compromised, they could cause serious or life-threatening infections or complications during the procedure.
- Check if you have one of the affected kits by matching the lot number on the package to the FDA recall notice.
- Do not use affected kits. Contact your healthcare facility or supplier for replacement kits.
- Report any adverse events or product problems to the FDA MedWatch program or Arrow International.
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-2363-2026Want us to check the next one for you?
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