Lidocaine Hydrochloride

Illinois-based supplier Medline has recalled thousands of cardiac procedure kits due to quality issues with the anesthetics included in the kits. Over 6,500 cardiovascular procedure kits used in open-heart surgery and 500 general surgery trays faced FDA’s Class I recall. All recalled kits included the tainted Lidocaine Hydrochloride Injection, USP and/or Bupivacaine Hydrochloride in Dextrose Injection, USP. Medline was forced to recall 22 lots. The supplier is urging users and distributors to “remove and discard the affected component prior to using the kit.” Medline has faced several other high-profile recalls in recent months. Earlier in June, the supplier recalled nearly 50,000 procedure kits used in the cardiac cath lab and other parts of the hospital due to safety concerns about liquid adhesive. In April, Medline issued an Urgent Medical Device Recall to affected customers recommending all Namic Angiographic Rotating Adaptor (RA) Control Syringes and Convenience Kits containing RA Syringes be removed from where they are used or sold because the syringe rotating adaptor on affected devices may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. The same month, FDA cited Medline for multiple violations at its Glen Falls, NY, facility. The Medline facility in question manufactures and assembles medical devices, including cardiovascular procedure kits and Namic angiographic control syringes. According to the warning letter, Medline failed to implement corrective and preventive action (CAPA) procedures. FDA said the company did not take actions commensurate with the risks identified for the Namic angiographic control syringes, despite receiving 221 complaints and filing 177 Medical Device Reports (MDRs) related to disconnections. In March, the company recommended that certain reprocessed electrophysiology and ultrasound catheters be removed from where they are used or sold including four St. Jude models, one Abbott model, two Biosense models, and two Acuson models over small residual particulates. In February, M edline issued an urgent medical device recall for 4,300 blood culture kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the packaging of the applicators. This packaging defect could cause sterility issues with the kits. In addition, the company is still reeling from a massive fire that destroyed Medline’s one-million-square-foot facility in Tracy, CA. News of the fire caused the company’s shares to drop by nearly 5%.