Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine Ampules

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.

Affected ProductThe FDA is aware that Argon Medical has issued a letter to affected customers recommending certain convenience kits be corrected prior to continued use by removing components affected by the Huons Co., Ltd. recall. Affected devices: Product NumberArgon Product NameLots / Batch NumbersUDI-DI497434One-Piece Introducer Tray 8F1165689100886333214495497455One-Piece/Tuohy-Borst Introducer Tray 8.5F1165898400886333214631008416ATransvenous Pacing Electrode Tray w/ Bipolar Pacing Electrode 5F 115cm1165689800886333217632008566ATransvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F 110cm11654475,1165447800886333217649400115AArterial Line Kit 20ga x 6"11655174, 11655183, 11655185, 1165913100886333212880BMET1104TLT-Lok™ Economy Bone Marrow Tray1165476400886333007608BMT1104CATLT-Lok™ Bone Marrow Tray1165088700886333007769BMT1104STLT-Lok™ Bone Marrow Tray w/ Safety Needle1165067900886333007868CB0033TLCustom Bone Marrow Tray11650820, 1165227600886333217304CB0355TLACustom Bone Marrow Tray1165197700886333217694GUTS1000General Biopsy Tray1164976000886333001590What to DoDo not use Lidocaine HCL included in affected kits.

Check your stock for convenience kits containing Lidocaine HCL ampules and quarantine until over-labels are provided. All remaining components within the kits may continue to be used.On June 1, Argon Medical sent all affected customers a letter recommending the following actions:Immediately check your stock for the affected item and lot numbers. Place over-labels on the affected product.

The labels provide instructions for staff to remove and discard the affected component prior to using the kitIf you have distributed, resold, or transferred affected products to other companies or individuals, notify them of this recall.Reason for CorrectionArgon Medical is issuing a recall for specific Argon Medical kits containing Spectra Medical Device, Inc. pain management kits with Huons lidocaine HCL Injection. Huons Co., Ltd.

initiated a recall of Bupivacaine HCL in Dextrose Injection, USP. Risks of using compromised injectables include infection, inflammatory response and/or reduced anesthetic effectiveness. When used in the neuraxial space, there is a risk of cerebral fluid contamination and meningitis that may progress to encephalitis and emergency conversion to general anesthesia.As of June 1, Argon Medical has reported 2 serious injuries and no deaths associated with this issue.Device UseConvenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.Contact InformationCustomers in the U.S.

with adverse reactions, quality problems, or questions about this recall should contact Argon Medical at quality.regulatory@argonmedical.com.Additional FDA Resources FDA Enforcement Report CDRH Medical Device Recall Database Huons Co., Ltd. Saline and Lidocaine Recall: FDA Enforcement ReportUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?

AccessGUDID database - Identify Your Medical Device Benefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.