Arrow International peritoneal lavage catheter kits recalled for compromised sterility of anesthetic components
What this means
Arrow International's 8FR peritoneal lavage catheter kits contain anesthetic medications (lidocaine and bupivacaine) from a supplier with known quality issues. If the sterility of these injectable components is compromised, patients could face serious injury or infection.
- Stop using affected kits immediately if you have them in inventory
- Check your lot numbers against the FDA's list to confirm if your kits are affected
- Contact Arrow International or your distributor for instructions on return or replacement
- Do not use any affected kits on patients
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-2380-2026Want us to check the next one for you?
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