FDA Alerts & Warnings

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

13. November 2009

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Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.

Synthes USA, Ti Synex II Vertebral Body Replacement – Class I Recall

12. November 2009

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Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device.

External Biphasic Defibrillators Energy Levels: Initial Communication

10. November 2009

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14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient.

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter – Class 1 Recall

9. November 2009

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Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery.

Hospira Brand Propofol and Liposyn Products – Recall

9. November 2009

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Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow.

Stiff Nights – product contains undeclared drug ingredient

5. November 2009

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Consumers warned that product sold as a dietary supplement contains sulfoaildenafil.

Centurion Medical Products – Premie Pack and Meconium Pack – Recall

4. November 2009

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Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label.

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials — Recall

3. November 2009

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Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product.

Dietary Supplements Sold on Internet by Bodybuilding.com

3. November 2009

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Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury.

Unomedical Manual Pulmonary Resuscitator – Recall

3. November 2009

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Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly.

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Archive | November, 2009

Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen

Synthes USA, Ti Synex II Vertebral Body Replacement – Class I Recall

External Biphasic Defibrillators Energy Levels: Initial Communication

Edwards Lifesciences CardioVations EndoClamp Aortic Catheter – Class 1 Recall

Hospira Brand Propofol and Liposyn Products – Recall

Stiff Nights – product contains undeclared drug ingredient

Centurion Medical Products – Premie Pack and Meconium Pack – Recall

Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials — Recall

Dietary Supplements Sold on Internet by Bodybuilding.com

Unomedical Manual Pulmonary Resuscitator – Recall

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