The U.S. Food and Drug Administration (FDA) has announced a Class I recall, the most serious type, for certain convenience kits distributed by Arrow International, a Teleflex subsidiary, due to components manufactured by Huons Co. Ltd.
The recall involves Arrow Kits and Sets containing 0.9% sodium chloride (10mL saline solution ampule) and Lidocaine, or Lidocaine and Bupivacaine. Arrow International is removing saline, bupivacaine, and lidocaine ampules from these kits, following a recall initiated by Huons Co. Ltd, the original manufacturer of these injectables.
Risks associated with using the compromised injectables include infection, inflammatory response, and reduced or absent anesthetic effectiveness. Ineffective pain control could lead to significant patient distress, surgical complications such as emergency conversion, or the need for repeat or delayed treatment. The FDA has identified this as a Class I recall, the most serious type, noting that it involves correcting devices rather than removing them. The agency warns that continued use without correction may cause serious injury or death.