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Gas Powered Emergency Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitator Due to An Undersized Spring in The Controller That May Prevent the Device from Delivering the Required Pressure Levels Needed for Effective Ventilation

Mercury Medical recalls the Neo-Tee T-Piece Resuscitator due to the controller potentially not delivering the pressure levels needed for effective ventilation.

http://www.fda.gov/medical-devices/medical-device-recalls/gas-powered-emergency-resuscitator-recall-mercury-medical-removes-neo-tee-t-piece-resuscitator-due

 
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Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen, Inc. is voluntarily recalling one lot of Fentanyl Transdermal System 25 mcg/h transdermal patches to the consumer level. The reason for the recall is that there is a potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch. This transdermal s

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/alvogen-issues-voluntary-nationwide-recall-one-lot-fentanyl-transdermal-system-25-mcgh-due-defective

 
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Glucose and Glucose/Ketone Meter Correction: Nova Biomedical Corporation Issues Software Correction for StatStrip Glucose and Glucose/Ketone Hospital Meters Due to Risk for Transmission of Incorrect Patient Results

StatStrip Hospital Glucose and Ketone Meters provide blood glucose and ketone readings in health care settings. A software issue may transmit inaccurate results to patient records.

http://www.fda.gov/medical-devices/medical-device-recalls/glucose-and-glucoseketone-meter-correction-nova-biomedical-corporation-issues-software-correction

 
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Olympus Issues Medical Device Advisory Notice to Use Alternative Devices to the MAJ-891 Forceps/Irrigation Plug

Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-medical-device-advisory-notice-use-alternative-devices-maj-891-forcepsirrigation-plug

 
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Provepharm Inc. Issues Voluntary Nationwide Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

Collegeville, Pennsylvania, Provepharm Inc. is voluntarily recalling lot number 24020027; Expiry Date December 2025 of Phenylephrine hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) at the hospital/institutional level. This recall was initiated based on a customer complaint from a pha

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/provepharm-inc-issues-voluntary-nationwide-recall-one-lot-phenylephrine-hydrochloride-injection-usp

 
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Copaxone, Glatopa (glatiramer acetate): Drug Safety Communication – FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

The FDA is warning about the risk of a rare but serious allergic reaction with the medicine glatiramer acetate (Copaxone, Glatopa), which is used to treat patients with multiple sclerosis (MS). This serious allergic reaction, called anaphylaxis, can occur at any time while on treatment, after the fi

http://www.fda.gov/safety/medical-product-safety-information/copaxone-glatopa-glatiramer-acetate-drug-safety-communication-fda-adds-boxed-warning-about-rare

 
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Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/max-mobility-permobil-issues-nationwide-recall-smartdrive-speed-control-dial-due-motor-being