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Recalls Of IV Solutions For Presence Of Particulate Matter
By RTT Staff Writer
Baxter (BAX) said it is voluntarily recalling two lots of intravenous solutions to the hospital/end user level due to the potential presence of particulate matter. The IV solutions are 0.9% Sodium Chloride Injection, USP, 250 mL, and 70 percent Dextrose Injection (2,000 mL) USP.
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes. It may also be used as a priming solution in hemo-dialysis procedures. 70% Dextrose Injection (2,000 mL) USP is indicated as a source of calories and water for hydration.
The particulate matter in each case was determined to be an insect and was identified after a customer complaint. The matter was identified before patient administration and there have been no adverse events associated with this issue so far.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels. This may lead to stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The lots being recalled were distributed to customers and distributors in the U.S. between June 6, 2015 and December 16, 2015.
For comments and feedback: [email protected]
Baxter (BAX) said it is voluntarily recalling two lots of intravenous solutions to the hospital/end user level due to the potential presence of particulate matter. The IV solutions are 0.9% Sodium Chloride Injection, USP, 250 mL, and 70 percent Dextrose Injection (2,000 mL) USP.
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container is intended for IV use as a source of water and electrolytes. It may also be used as a priming solution in hemo-dialysis procedures. 70% Dextrose Injection (2,000 mL) USP is indicated as a source of calories and water for hydration.
The particulate matter in each case was determined to be an insect and was identified after a customer complaint. The matter was identified before patient administration and there have been no adverse events associated with this issue so far.
Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels. This may lead to stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, local irritation and inflammation in tissues and organs.
The lots being recalled were distributed to customers and distributors in the U.S. between June 6, 2015 and December 16, 2015.
For comments and feedback: [email protected]