# Ne oldu?
Baxter International Inc. has voluntarily recalled one lot of 70% Dextrose Injection (NDC 2B0296H) due to potential presence of stainless steel particulate matter. Intravenous administration may cause serious adverse events including vessel blockage, pulmonary embolism, organ damage, or death. No adverse events have been reported to date. The affected product is packaged in 2000 mL VIAFLEX Plastic Containers (6 units per case).
# Ayrıntılar
The recall is nationwide and involves a single lot of the product. The affected lot number is 2B0296H. The product is 70% Dextrose Injection, USP, supplied in 2000 mL VIAFLEX Plastic Containers, with six units per case. Baxter has stated that as of the recall announcement, no adverse events have been reported to date related to this specific issue. The product is used as a source of calories and fluid replenishment when mixed with amino acids or other compatible intravenous fluids for parenteral nutrition, typically when oral or enteral nutrition is not possible, insufficient, or contraindicated.
# Neden önemli?
Intravenous administration of a contaminated solution can lead to serious adverse health consequences. Particulate matter can cause blockage and clotting in blood vessels, which can cut off blood flow to vital organs. This may lead to a life-threatening blood clot in the lungs (pulmonary embolism) and cause permanent organ damage or death. Given that this product is used in clinical settings for patient nutrition, the presence of stainless steel particles poses a significant risk to vulnerable patient populations.
# Arka plan
Parenteral nutrition is a critical method of providing nutrients and fluids intravenously when a patient cannot receive nutrition orally or enterally. This is common in hospital settings for patients with severe illness, gastrointestinal dysfunction, or those requiring long-term nutritional support. Baxter is a well-known entity in the healthcare industry, and the company has a history of proactive safety measures. This recall underscores the importance of rigorous quality control in the manufacturing of intravenous solutions to ensure patient safety.
# Sırada ne var?
Healthcare professionals and pharmacists are advised to check the lot numbers of 70% Dextrose Injection products in their inventory. The specific affected lot is 2B0296H. Products matching this lot should be quarantined and not administered to patients. Baxter is working with the FDA and distributors to ensure the affected product is removed from the supply chain. Further communication regarding the recall and any updates on the investigation will be provided by Baxter and regulatory agencies. No additional lots have been identified as affected at this time.
