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 Product
The FDA is aware that Medical Action Industries has issued a letter to affected customers recommending certain epidural kits 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 Number | UDI |
|---|---|---|---|
| 82465 | Kit: Epidural/Pain TQC 20/Cs | 329618 | 10809160367414 |
| 59553 | Kit: Single Shot Epidural 20/Cs | 330274 | 10809160010518 |
| 59553 | Kit: Single Shot Epidural 20/Cs | 331036 | 10809160010518 |
| 59553 | Kit: Single Shot Epidural 20/Cs | 332995 | 10809160010518 |
| 82465 | Kit: Epidural/Pain TQC 20/Cs | 347199 | 10809160367414 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 330827 | 10809160444269 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 330907 | 10809160444269 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 333956 | 10809160444269 |
| 82465 | Kit: Epidural/Pain TQC 20/Cs | 337283 | 10809160367414 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 350340 | 10809160444269 |
| 59553 | Kit: Single Shot Epidural 20/Cs | 333957 | 10809160010518 |
| 59553 | Kit: Single Shot Epidural 20/Cs | 338894 | 10809160010518 |
| 82465 | Kit: Epidural/Pain TQC 20/Cs | 350354 | 10809160367414 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 351266 | 10809160444269 |
| 83945B | Kit: Single Shot Epidural 20/Cs | 373674 | 10809160444269 |
| 82465 | Kit: Epidural/Pain TQC 20/Cs | 375449 | 10809160367414 |
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 MAI 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 Alert
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
- Related Downstream Recalls
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.
