Epidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules

What to Do

Do not use sodium chloride ampules included in affected kits. Check your stock for epidural 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 July 23, Medical Action Industries sent all affected customers a letter recommending the following actions:

• Identify, Segregate, and Quarantine all impacted kits.
• Add warning labels to affected Medical Action Industries 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.

Reason for Correction

Medical Action Industries stated that epidural kits may contain sodium chloride ampules manufactured by Huons Co., Ltd. and recalled by Spectra Medical Devices, LLC.

If the sterility of the sodium chloride injection (flush solution) is compromised, patients may be exposed to viable microorganisms, endotoxins, and/or foreign matters generated during manufacturing. This can trigger systemic inflammatory responses, infections, micro-clots, and organ failure. Use in close proximity to the spine may lead to abscess formation, infection of the meninges, and compression injury of the spinal roots leading to paralysis and death.

As of July 23, Medical Action Industries has not reported any serious injuries or deaths associated with this issue.

Device Use

Spinal epidural anesthesia kits are sterile, single-use procedural trays containing needles, catheters, and other accessories intended to be used during epidural procedures.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medical Action Industries at complaints@owens-minor.com.

Additional FDA Resources

• FDA Enforcement Report
• CDRH Medical Device Recall Database
• Related Downstream Recalls
  • Spectra Medical Devices Sodium Chloride Flush Recall: FDA Enforcement Report
  • Huons Co., Ltd. Saline and Lidocaine Recall: FDA Enforcement Report

Unique 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 System

How 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. 

Timeline of Communication Updates