Arrow International peritoneal lavage catheter kits recalled for compromised sterility of anesthetic components
Arrow International peritoneal lavage kits recalled for sterility risk
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
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-2380-2026More Arrow recalls
- FDA-Device2026-06-24Arrow International hemodialysis kits recalled for contaminated anesthetic and saline solutions
- FDA-Device2026-06-24Arrow International PI CVC kits recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International PICC kits and stylets recalled for compromised sterility and drug ineffectiveness
- FDA-Device2026-06-24Arrow International PICC and JACC catheter kits recalled for contaminated anesthetic and saline components
- FDA-Device2026-06-24Arrow International Pacing PSI Kits recalled for potential drug ineffectiveness and sterility compromise
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