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The FDA is aware that Arrow International has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use. Affected devices:
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Arrow Kits and Sets that contain 0.9% sodium chloride (10mL saline solution ampule) and Lidocaine
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Arrow Kits and Sets containing Lidocaine and Bupivacaine
Arrow International, a Teleflex subsidiary, is removing saline, bupivacaine and lidocaine ampules manufactured by Huons Co. Ltd from certain convenience kits. Huons Co., Ltd. initiated a recall of saline, bupivacaine and lidocaine.
Risks of using compromised injectables include infection, inflammatory response and/or reduced or lack of anesthetic effectiveness. Use of Lidocaine or bupivacaine with reduced or lack of anesthetic effectiveness, may result in ineffective pain control leading to varying degrees of pain, surgical complications, such as emergency conversion and/or repeat or delayed treatment, and/or patient distress.
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Arrow International at Recalls@teleflex.com or 1-866-396-2111.
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