Arrow

Arrow International recalled several PICC (peripherally inserted central catheter) kits and stylets because they contain injectable medications from a supplier with quality issues. The medications—lidocaine, bupivacaine, and saline—may be ineffective or contaminated, which could cause serious injury if used.

Arrow International included local anesthetic drugs (lidocaine and bupivacaine) from a supplier with quality issues into several pacing procedure kits. The supplier's drugs had limited reports of ineffectiveness, and compromised sterility in injectable products could cause serious infection or other life-threatening complications.

Arrow International included anesthetic medications (lidocaine and bupivacaine) and saline solution from a supplier with quality problems in its biopsy system kits. The supplier had reports of drug ineffectiveness, and compromised sterility in injectable products could cause serious injury.

Arrow International included lidocaine, bupivacaine, and saline solutions from a supplier with quality problems in multiple anesthesia and nerve block kits. The supplier's products may be ineffective or contaminated, which could cause serious infection or other life-threatening complications if the sterility of these injectable solutions is compromised.

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.

A supplier defect in the 16F dual-valved splittable sheath introducer used in certain Arrow NextStep hemodialysis catheter kits may prevent the sheath from splitting as designed. This can cause difficulty during catheter placement, leading to prolonged procedures and potential complications including bleeding, tissue injury, or vessel wall damage.

A faulty component supplied by a vendor — a 16F dual-valved splittable sheath introducer — was included in certain Arrow International hemodialysis catheter kits. The sheath may fail to split as designed during insertion, potentially causing procedural delays, pain, bleeding, bruising, or tissue damage.

Arrow International is recalling specific lots of Arrow-Clark VectorFlow hemodialysis catheters because they contain a faulty sheath introducer component from a supplier. The introducer may fail to split properly during insertion, which could cause difficulty withdrawing the device, prolonged procedure time, pain, and potential bleeding or tissue injury.

Arrow International included a defective 16F dual-valved splittable sheath introducer in certain hemodialysis catheterization kits. The sheath introducer may not split properly during removal, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, and tissue or vessel wall injury.