Spectra 0.9% saline flush recalled for sterility concerns
Spectra Medical Devices is recalling its 0.9% Sodium Chloride Injection 10mL ampules (model AMPUL10MLK), used as flushes in IV tubing and indwelling access devices. The manufacturer, Huons, was cited for product quality and sterility problems. If sterility is compromised, patients could be exposed to microorganisms, endotoxins, or foreign matter, which may cause infections, inflammation, or micro-clots.
From the FDA notice · Read the official notice ↗
What to do
- Check whether any convenience kits you use contain Spectra 0.9% Sodium Chloride ampules, model AMPUL10MLK.
- Compare kit lot codes against the affected lots, AB3005 through AB5008 (product codes 1510-1 and 1510-2).
- Contact Spectra Medical Devices or your kit supplier for instructions on affected kits.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.
- Sold in
- Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.
- Made for
- All ages (0 months and older)
Details
- Units affected
- TBD
- Illnesses reported
- None reported
- Manufactured in
- 299 Ballardvale St, Ste 1, Wilmington, MA, United States
- Classification
- Class I
- Recall number
- Z-2873-2026
In the FDA's words
- Description
- Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9%, USP 10mL Ampule Model/Catalog Number: AMPUL10MLK. Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices. Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure. Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton) Lots: AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005 AB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008 No individual UDI, as this product is used only within convenience kits. Distribution: Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA. Affected quantity: TBD
- Hazard
- Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.