Baxter Heparin Recall History
The Baxter Heparin recall is one of many previous recalls Baxter Healthcare has undertaken. Below is a shortened list that ends with the Baxter Heparin recall in 2008.
- 2000 Recall
- Immune Globulin Intravenous Iveegam EN
- 2001 Recall
- Amicus Separator
- Albumin 5% Buminate
- 2002 Recall
- Automated Blood Cell Separator
- Blood Pack PL 732 Transfer Pack
- 2003 Recall
- Triple Blood Pack PL 732 Transfer Pack
- 2004 Recall
- Immune Globulin Intravenous GAMMAGARD
- Amicus Separator Apherisis Device
- 2005 Recall
- Amicus Separator
- Blood Pack [multiple models]
- COLLEAGUE Volumetric Infusion Pump
- 2008 Recall
- Heparin Injection [single and multiple dose]
Baxter Heparin Recall Reports
Early in January 2008, Baxter Healthcare, the Centers for Disease Control, and the US Food and Drug Administration received 350 reports detailing adverse reactions to Baxter Heparin. The Baxter Heparin recall was a direct result of the unusual quantity of reports sent to Baxter Healthcare and the US FDA. Most of these Baxter Heparin recall reports specified events occurring at dialysis centers.
The Baxter Heparin reactions and symptoms are varied, and as follows.
- General Malaise
- Oral Swelling
- Nausea or Dizziness
- Vomiting or Retching
- Black Outs or Fainting
- Abdominal or Stomach Pain
- Chest Pain
- Diarrhea
- Sweating
- Shortness of Breath
- Skin Discoloration
- Decreased Drug Effectiveness
- Decrease Responsiveness
- Decreased Blood Pressure
The serious and life threatening reactions – 40% of the reports – prompted the first phase of the Baxter Heparin recall. The resulting decreased blood pressure or hypotension causes organ damage, organ failure, shock, and death.
Baxter Heparin Recall Investigation
On 17 January 2008, the Baxter Heparin recall began with the multiple-dose Heparin injection lots of 1000 units/mL at 10mL and 30mL multiple dose vials.
Inspectors and medical specialists from Baxter Healthcare, the CDC, and the US FDA began working independently and collaboratively to investigate the cause of the Baxter Heparin effects. Due to the gravity of the events, outside and foreign experts were likewise consulted.
Baxter Heparin Recall Summary
On 28 February 2008, the Baxter Heparin recall included all injection lots.
- Single Dose 10,000 USP units/mL
- Single Dose 5,000 USP units/mL
- Single Dose 1,000 USP units/mL
- Multiple Dose 10,000 units/mL
- Multiple Dose 5,000 units/mL
- HEP-LOCK 10 and 100 USP units/mL
- HEP-LOCK U/P 10 and 100 USP units/mL
The Baxter Heparin recall came after Baxter Healthcare was linked to as many as 400 life threatening events and 21 deaths.
The Baxter Heparin was used primarily for dialysis, cardiac surgery, and other serious medical conditions. If you have undergone any of these procedures, you may have been administered a contaminated dose of the drug. Consult your physician immediately.
The attorneys at Babbitt-Johnson are continually investigating the legal ramifications of the negligence of Baxter Healthcare. Free consultations are offered to provide legal recourses for victims of Baxter Heparin and its adverse effects.
It is imperative to consult a physician as soon as possible. Babbitt-Johnson attorneys, specializing in aprotinin and Trasylol cases, offer free legal consultations and advice on the best legal recourses.
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