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Tag Archives: Baxter Recall

FDA Guidance Seeks to Eliminate Heparin Contamination Risk

  • Written by: Staff Writers
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Federal health regulators have drafted new industry guidelines that are designed to ensure the quality of heparin following the deaths of nearly 150 people several years ago when contaminated batches of the blood thinner made it into U.S. pharmacies and hospitals. …

FDA Issues Baxter Infusion Pump Recall Requirements

The FDA has laid out requirements for the recall of Colleague Volumetric Infusion pumps by Baxter Healthcare Corp., instructing the company on how to refund or provide replacements for about 200,000 potentially dangerous infusion pumps. …

Hylenex Recall: Baby Rehydration Fluids Contaminated with Glass Flakes

Baxter International Inc. is recalling about 3,200 vials of Hylenex, a pediatric rehydration medication, due to glass flake contamination. Halozyme Therapeutics, a company partnered with Baxter to manufacture Hylenex, has issued a breach notice against Baxter and is threatening to terminate their partnership due to the recall. …

Baxter Infusion Pump Recall: Pump Failure Could Result in Death

Baxter Colleague Infusion pumps, which are widely used at hospitals throughout the United States to deliver IV fluids and medicine, have been recalled by the FDA because the devices could delay or interrupt the infusion of fluids, potentially resulting in serious personal injury or death.…

Heparin Recall Lawsuits

Beginning around November 2007, the FDA started receiving a large number of reports involving adverse events associated with allergic-type reactions to heparin. Subsequent investigations have uncovered that a large portion of the heparin sold in the United States around this time was contaminated with a fake ingredient. In early 2008, a nationwide Baxter Heparin Recall was issued involving nearly half of the supply of injectible heparin sold in the U.S. Other forms of the blood thinner made from the same raw ingredients have also been recalled.…