Early Alert: Convenience Kit Issue from AVID Medical

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. Affected ProductThe FDA is aware that AVID Medical has issued a letter to affected customers recommending certain convenience kit be corrected prior to continued use by removing components affected by the Huons Co., Ltd.

recall.Affected devices: Model/Item Number (Kit)Description (Tray Name)Kit Lot NumberUDIBMCN001-05CONTINUOUS NERVE BLOCK TRAY170312210809160455128BMCN001-05CONTINUOUS NERVE BLOCK TRAY170765610809160455128BMCN001-05CONTINUOUS NERVE BLOCK TRAY170805310809160455128DPGE002-0218G SINGLE SHOT EPI TRAY164171310809160410325DPGE002-0218G SINGLE SHOT EPI TRAY164171410809160410325DPGE002-0218G SINGLE SHOT EPI TRAY165969710809160410325DPGE002-0218G SINGLE SHOT EPI TRAY166820910809160410325PM415BASIC BIOPSY TRAY165248510809160322154PM415BASIC BIOPSY TRAY165664210809160322154PM415BASIC BIOPSY TRAY166783510809160322154PM415BASIC BIOPSY TRAY167621910809160322154PM415BASIC BIOPSY TRAY168225110809160322154PM415BASIC BIOPSY TRAY169194010809160322154VARV042-03UNIV IMAGING BIOPSY TRUCUSTOM166836510809160490822VARV042-03UNIV IMAGING BIOPSY TRUCUSTOM166836610809160490822VARV042-03UNIV IMAGING BIOPSY TRUCUSTOM168816610809160490822VARV042-03UNIV IMAGING BIOPSY TRUCUSTOM169263710809160490822VARV042-03UNIV IMAGING BIOPSY TRUCUSTOM169693010809160490822What to DoDo not use sodium chloride ampules included in affected kits. Check your stock for convenience kits containing sodium chloride ampules. Quarantine kits until new labels can be printed and affixed to all kits.

All remaining components within the kits may continue to be used.On August 10, AVID Medical sent all affected customers a letter recommending the following actions:Identify, Segregate, and Quarantine all impacted kits. Add warning labels to affected convenience kits to ensure all users are aware of the actions to take prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory.This label should be applied in a prominently visible location to end-users.

The location chosen should not cover any other critical product information found on existing product labeling. If pre-printed labels are needed, please contact your sales representative. REMOVE AND DISCARD the Sodium Chloride, 0.9%, USP 10 mL Flush ampules prior to use.Check this web page for updates.

The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. Reason for AlertAVID Medical stated that epidural kits may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC, due to concerns of product quality and sterility assurance in the Sodium Chloride Injection 0.9%, USP 10ml.

The use of sodium chloride ampules may expose patients to viable microorganisms, endotoxins, and foreign matter that may trigger inflammatory responses and infections. This consideration is of particular importance in critically ill patients and when treatment is administered in close proximity to organs highly susceptible to injury — such as the spinal cord — where it may predispose to abscess formation and subsequent paralysis.As of August 10, AVID Medical has reported no 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 issue should contact AVID Medical at complaints@owens-minor.com.Additional FDA ResourcesRelated Recalls Spectra Medical Devices Sodium Chloride Flush Recall: FDA Enforcement Report 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.