Voluntary Recall for Sodium Chloride Injection 0.9%, USP 10ml indicated for flush applications
URGENT: MEDICAL DEVICE RECALL
SODIUM CHLORIDE INJECTION, 0.9%, USP 10ml ampules INDICATED AS A FLUSH
SPECTRA MEDICAL DEVICES, LLC
A SUBSIDIARY OF ELEVARIS MEDICAL DEVICES, INC.
299 BALLARDVALE STREET, SUITE 1,
WILMINGTON, MA 01887
July 6, 2026
Dear Customer / Distributor:
Purpose of this Letter:
The purpose of this letter is to advise you that Spectra Medical Devices, LLC is voluntarily recalling Sodium Chloride Injection 0.9%, USP 10ml indicated for flush applications (the “Sodium Chloride Flush”) that are within expiry, for the lots listed in Appendix 2.
Reason for the Voluntary Recall:
The Sodium Chloride Flush was manufactured for Spectra Medical Devices, LLC, a subsidiary of Elevaris Medical Devices, Inc. (“Spectra”) by Huons Co., Ltd. (“Huons”), located in Korea between April 1, 2023, and March 5, 2026. In November of 2025, Huons underwent an unannounced FDA inspection and was issued an FDA inspection report reflecting observations related to product quality and sterility assurance on certain production lines.
Out of an abundance of caution, Spectra is conducting a voluntary recall of its Sodium Chloride Flush product. Since April 1, 2023, Spectra has received no complaints about its Sodium Chloride Flush product related to endotoxin or sterility, or for any other reason.
Risk to Patient Health:
If 0.9% Sodium Chloride Injection/Flush solution's 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.
Actions to be taken by Customer:
Spectra requests that you take the following actions:
Examine your stock immediately and discard or return any unused Sodium Chloride Flush ampules bearing the lot numbers listed in Appendix 2 of this letter to:
Spectra Medical Devices, LLC
ATTENTION: QUALITY ASSURANCE DEPARTMENT
299 Ballardvale Street, Suite 1,
Wilmington, MA 01887
For affected products already in distribution, instruct customers to discard or return products 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. Adverse reactions or quality problems can be reported to MedWatch: the FDA Safety Information and Adverse Event Reporting Program using an online form, by regular mail or by fax.
Please provide a “Customer Shipment Report” that lists all devices shipped to customers. The report should include the Shipment Date, Customer Name and Address, REF Number, Lot Number, and Quantity. This information is important to determine removal effectiveness.
As the recipient of this communication, please complete the following actions:
Complete the attached Recall Acknowledgment Form, to enable us to track communication effectiveness. This form must be returned via e-mail to RecallCoordinator@elevarismedical.com. Spectra will credit your account for any returned product that is unused and unexpired. Billing information for return product shipment is available via the email contact. This email is monitored between 8:00 am to 4:30 pm Eastern Time.
PLEASE FILL OUT AND RETURN THE RESPONSE EVEN IF YOU HAVE NONE OF THESE ITEMS ON HAND.
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.
This communication is intended to be conveyed to the wholesale, hospital and / or medical practitioner / healthcare provider levels. This communication is being made with the knowledge of the U.S. Food and Drug Administration.
For any questions, please email RecallCoordinator@elevarismedical.com.
We sincerely regret the inconvenience this will cause you, but we know that you share with us the desire to maintain the highest quality standards in our products.
Sincerely,
Lisa A. Perronne
VP Quality & Regulatory
Enclosures:
Recall Response Form
Customer Shipment List
Appendix 1: EXAMPLE CARTON LABEL
EXAMPLE SINGLE UNIT LABEL
Appendix 2: Product Lot List
NOTE: There is not an individual UDI for the Sodium Chloride Flush product, as this product is used only within convenience kits. Per 1 CFR §801.30(a)(11) — UDI Exception for Convenience Kits: “A device packaged within the immediate container of a convenience kit, provided that the label of the convenience kit bears a UDI.”