Sodium Chloride Flush Recall Issued by Spectra Medical Devices
Spectra Medical Devices has issued a recall for specific lots of Sodium Chloride Injection 0.9%, USP 10mL flush ampules manufactured by Huons Co., Ltd. The action follows an FDA manufacturing facility inspection that identified quality issues which could potentially compromise product sterility.
Compromised sterility may expose patients to viable microorganisms, endotoxins, or foreign matter, risking systemic inflammatory responses, infections, micro-clots, and organ failure, particularly in high-risk groups. No serious injuries or deaths had been reported at the time of the notice.
Healthcare providers and facilities are advised to immediately examine their inventory, stop using affected products, and discard or return any unused units as instructed by the distributor.
Key points
- Affected product: Sodium Chloride Injection 0.9%, USP 10mL, catalog codes AMPUL10MLK, 1510-1, and 1510-2.
- Recall initiated due to quality issues identified during an FDA manufacturing facility inspection.
- Compromised sterility can lead to infections, systemic inflammation, micro-clots, and organ failure.
- Providers should check inventory immediately, discard or return affected stock, and monitor patients for adverse events.
What it means for you
Clinicians and pharmacists should check their stock for the affected Spectra Medical sodium chloride flush ampules and immediately quarantine and return or discard any identified units. Healthcare professionals must remain vigilant for potential infections or inflammatory responses related to these devices. Clinicians in Pakistan should check with DRAP for any local availability or alerts regarding these specific imported items.
Sodium Chloride Flush Recall: Spectra Medical Removes Sodium Chloride Injection USP Ampules
Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.