Heparin Sodium Injection Vial Recall - What you should know...

Baxter Healthcare Corporation announced on January 25, 2008 an urgent voluntary recall of it's Heparin Sodium Injection Vials, a prescription blood thinner injection often used in hemodialysis (the filtering of blood) and invasive cardiac procedures, after it received complaints about adverse reactions to the drug far above normal levels. The company has reported that patients are subject to a variety of reactions – some of which could be life threatening.

The FDA has classified this recall as a Class I recall, the most urgent recall of its kind, stating that there is "reasonable probability that use of the product will cause serious injury or death." Customers are instructed to immediately stop using the product, to quarantine all products in their inventory and to return them to the distributor.

Baxter, in the past, has received reports of allergy-type reactions linked to Heparin. The company said it normally receives 60 to 70 reports during a given year of possible reactions to heparin, but it has received around 150 such reports already in January, with one death at a Florida hospital possibly linked to the Baxter Heparin recall.

Adverse reactions from Heparin may include:
stomach pain or discomfort nausea vomiting diarrhea low blood pressure chest pain fast heart rate dizziness fainting unresponsiveness shortness of breath tachycardia drug ineffectiveness	burning sensation redness or paleness of skin abnormal sensation of the skin mouth, or lips flushing increased sweating decreased skin sensitivity headache feeling unwell restlessness watery eyes throat swelling thirst difficulty opening the mouth

This is not the first time that Baxter's Heparin vials have caused problems. In February 2007 the FDA, in collaboration with Baxter, issued a two-page safety alert warning of the fatal dangers of mistaking high 10,000 unit dose vials and low 10 unit dose vials of Heparin. The memo advised hospitals to double-check their inventory to ensure dispensing errors do not occur. The 2007 alert was issued after three infants died in Indiana after they were mistakenly given adult doses.

In December 2007, actor Dennis Quaid and his wife named Baxter in a lawsuit after their newborn twins were mistakenly given potentially fatal overdoses of heparin because of a vial mix up. In addition to the Quaid twins, at least six newborns and two other patients are known to have received an overdose of heparin since 2001.

According to the Baxter recall notice, no deaths have been reported in connection with the recalled Heparin vials. However, it is now being reported that one patient at HealthPark Medical Center in Lee County Florida has died, and four others have suffered reactions that could be linked to the Heparin recall. State and Federal authorities are investigating the incident, and according to the report, Baxter is expected to visit the facility to see if the patient's death and the other reactions were linked to the recalled Heparin.

The batches affected are as follows.

Lots:
107054
117085
047056
097081
107024
107064
107066
107074
107111

Your time may be short to collect compensatory or punitive damages for your serious injuries. If you or a family member have suffered any of the above mentioned symptoms, contact us now for a free, private consultation. Knowledge is power - we'd like to help you!