Category Archives: FDA Recall

Brilliant Blue G Recall

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Brilliant Blue G: Recall of Unapproved Drug – Ongoing Investigation of Fungal Endophthalmitis Cases AUDIENCE: Ophthalmology, Risk Manager ISSUE: FDA has received reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G (BBG) during eye surgeries. Clinicians … Continue reading

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Posted in FDA 2012, FDA Recall, Ophthalmology, Risk Manager | Tagged , , , , , , , , , , , , | Comments Off

Acclarent Inspira AIR Balloon Dilation System Class 1 Recall

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Acclarent Inspira AIR Balloon Dilation System: Class 1 Recall – Potential For Balloon To Not Deflate Or To Deflate To Slowly AUDIENCE: Emergency Medicine, Risk Managers ISSUE: Acclarent received four reports of incidents, one resulting in patient injury, in which … Continue reading

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Gerber Good Start Gentle Powdered Infant Formula Recall

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Gerber Good Start Gentle Powdered Infant Formula: Recall – Off-Odor AUDIENCE: Consumers, Pediatrics ISSUE: Gerber notified the public that it recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the affected product might … Continue reading

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Automated External Defibrillators AEDs Class I Recall

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Cardiac Science Powerheart, CardioVive, CardioLife; GE Responder and Responder Pro; and Nihon-Kohden Automated External Defibrillators (AEDs): Class I Recall – Defective Component Affected Models include: Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E CardioVive 92532, 92533 CardioLife 9200G and 9231 GE … Continue reading

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Posted in Cardiology, Emergency Rooms, FDA 2012, FDA Recall, Risk Manager | Tagged , , , , , , , , , , , , , , | Comments Off

Flight Medical V240040029 Cable for Newport HT50 Ventilator Class I Recall

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Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly   ISSUE: The recalled cable may cause an electrical shortage that can cause Newport HT50 … Continue reading

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Posted in Emergency Rooms, FDA 2012, FDA Recall, Hospitals, Risk Manager | Tagged , , , , , , , | Comments Off

Cytarabine for Injection 1 gm vial Bedford Labs Recall

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Cytarabine for Injection, 1 gm/vial [Bedford Labs]: Recall: Risk of Lack of Sterility ISSUE: Bedford Laboratories announced a nationwide recall of three lots of cytarabine for injection—2066986, 2111675, and 2131148—because vials have a potential risk of a lack of sterility. The risk … Continue reading

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Posted in Clinics, Emergency Rooms, Family Practice, FDA 2012, FDA Recall | Tagged , , , , , , , , , , , , | Comments Off

Infants TYLENOL Oral Suspension 1 oz Grape Recall

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Infants’ TYLENOL Oral Suspension, 1 oz. Grape: Recall – Dosing System Complaints AUDIENCE: Consumer, Pharmacy ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There … Continue reading

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