Arrow International arterial catheter kits recalled for compromised sterilization of injectable anesthetic
Arrow International arterial catheter kits recalled for sterilization concerns
Arrow International recalled multiple arterial catheter kits because they contain lidocaine, bupivacaine, and saline solution from a supplier with quality control issues. If the sterilization of these injectable products was compromised, patients could face serious or life-threatening infections.
- If you have one of the affected kits, do not use it.
- Contact your facility's pharmacy or medical device manager immediately with the product lot number.
- Follow your institution's procedures for handling recalled medical devices.
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-2397-2026More 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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