FDA closed nearly 700 Baxter infusion pumps

Baxter said on Tuesday that the FDA has closed nearly 7,000 intravenous infusion pumps in its inventory and sequestered more than 6,000 infusion pumps and 850 Syndeo PCA injection pumps. Earlier this year, the company stopped selling infusion pumps for a number of safety issues.
Baxter Company said that the FDA seized its inventory of products, and has been sold in the market products are not affected. It will discuss the matter with the FDA. FDA officials still can not comment on the matter immediately.
About 250,000 Colleague infusion pumps are currently available worldwide, over 200,000 in the United States alone. In addition, in late 2003, 5,000 Syndeo syringe pumps were sold worldwide.
Baxter spokesman Cindy Resman said Baxter has automatically halted the sale of its Colleague pump and Syndeo syringe pump in July because of product design and safety issues. The company has informed hospitals and other health care providers about the pitfalls of these products.
FDA recalls the product as a "first-class" recall, so Baxter states on July 21 that the Colleague infusion pump accidentally shut itself down while delivering medication and fluids. However, in this statement, no mention was made of the problems associated with the Syndeo Syringe Pump or the fact that the product has been banned for sale.
She said that because the FDA classifies the Syndeo syringe pump as a "second-level" recall, it is not necessary to state a problem with the Syndeo syringe pump in the statement, which is less harmful to the human body. Baxter has developed a "Corrective Action Plan" for these products and is prepared to discuss the matter with the FDA.

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