Drugs

Argon Medical Convenience Kit Correction is Class I Recall

FDA has classified a correction involving certain Argon Medical convenience kits as a Class I recall after identifying risks associated with lidocaine ampules supplied as components in the kits. The action does not require removal of the kits from hospitals or other users, but instead instructs customers to remove and discard the affected lidocaine ampules before the kits are used.

The correction affects multiple Argon Medical convenience kits used in vascular access, transvenous pacing, arterial line placement, bone marrow procedures and biopsies. According to an FDA notice, the affected products contain Spectra Medical Device pain management kits with Huons lidocaine HCL injection. Argon Medical notified affected customers on 6/1, instructing them to inspect inventory, apply over-labels to affected kits directing healthcare personnel to remove the impacted component before use, and notify downstream customers if the products had been redistributed.

The correction stems from a recall initiated by Huons Co., Ltd. involving injectable anesthetic products. FDA said use of compromised injectable anesthetics could result in infection, inflammatory reactions or reduced anesthetic effectiveness. When used in the neuraxial space, contaminated injectables could expose patients to cerebrospinal fluid contamination, meningitis, progression to encephalitis, and the need for emergency conversion to general anesthesia.

As of 6/1, Argon Medical had reported two serious injuries related to the issue and no deaths, FDA said.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome