Archive | September, 2010
Infant Sleep Positioners: Consumer Warning – Risk of Suffocation
FDA and Consumer Product Safety Commission have received 12 reports of babies known to have died from suffocation associated with sleep positioners.
Continue reading...Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal – Risk of Thromboembolic Events
24. September 2010
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UPDATED 09/24/2010. Market withdrawal of all lots of product until root cause of previously reported thromboembolic events can be determined and corrected.
Continue reading...Epogen and Procrit (epoetin alfa): Recall – Particulate Matter in Vials
24. September 2010
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Recall due to risks of embolic, thrombotic and other vascular serious adverse events.
Continue reading...Similac Powder Infant Formulas: Recall
24. September 2010
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UPDATE 09/24/2010. FDA has created a searchable database to find lot numbers of affected products.
Continue reading...Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns
24. September 2010
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Device overheating may result in serious 1st to 3rd degree patient burns.
Continue reading...BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall
15. September 2010
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Select lots have a potential for disconnection at the retention ring of the patient port manifold which could result in treatment delays.
Continue reading...Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients
15. September 2010
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New dosing recommendations to prevent potential overdose in pediatric transplant patients
Continue reading...Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall
10. September 2010
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Potential for the device to fail to detect air in line at the end of an infusion.
Continue reading...Gadolinium-based Contrast Agents: Class Labeling Change – Risk of Nephrogenic Systemic Fibrosis
9. September 2010
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New recommendations in labeling for screening for renal disease prior to use and monitoring for the development of NSF.
Continue reading...AngioSculpt “EX” PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall – Risk of Catheter Separation
8. September 2010
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Fragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death.
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29. September 2010
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