This recall involves removing devices 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.
Affected Product
The FDA is aware that Elevaris Medical Devices, doing business as Spectra Medical Devices, has issued a letter to affected customers recommending certain Sodium Chloride Flush products affected by the Huons Co., Ltd. recall be removed from where they are used or sold.
Affected devices:
- Product Name: Sodium Chloride Injection 0.9%, USP 10mL
- Product/Catalog Code:
- AMPUL10MLK
- 1510-1 (individual ampule)
- 1510-2 (carton)
- Full list of affected lots
What to Do
Examine your stock immediately and discard or return any unused Sodium Chloride Flush ampules affected by this recall.
On July 6, Spectra Medical Devices sent all affected customers a letter recommending the following actions:
- Examine your stock immediately and discard or return any unused Sodium Chloride Flush ampules affected by this recall
- For affected products already in distribution, instruct customers to discard or return unused product.
- Use extra vigilance in detecting and reporting potential patient health concerns that may be related to the Sodium Chloride, 0.9%, USP 10 mL Flush ampules.
- Forward this communication to each of your customers who have been shipped affected product. It is important that you contact each of your customers who have been shipped this material to ensure that it is immediately removed from their stock and use, where applicable.
Reason for Recall
Spectra Medical Devices is removing Sodium Chloride Flush products that were manufactured by Huons Co., Ltd. (Huons). Huons initiated a recall of Sodium Chloride Injection 0.9%, USP following an FDA inspection of its manufacturing facility, which identified quality issues.
If the products’ sterility is compromised, viable microorganisms, endotoxins, and/or foreign matters that are generated during manufacturing may be exposed to patients. They can trigger systemic inflammatory responses, infections, micro-clots, and organ failure, especially in high-risk populations.
As of July 6, Spectra Medical Devices has not reported any serious injuries or deaths associated with this issue.
Device Use
This product is intended for flushing compatible intravenous tubing systems and in-dwelling intravascular access devices.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Spectra Medical Devices at [email protected].
Additional FDA Resources
- FDA Enforcement Report
- CDRH Medical Device Recall Database
- Huons Co., Ltd. Saline and Lidocaine Recall: FDA Enforcement Report
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.