Recalls and Safety Alerts:
I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I RecallBolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position...
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I RecallIncorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions...
CareFusion Alaris Pump Module Model 8100: Class I RecallRecall due to reports of motor stalls during infusion with model 8100...
CareFusion 303, Alaris Pump Module, Model 8100: Class I RecallPump module door keypad overlay may become loose, peel away, or separate from the door assembly...
Synthes Hemostatic Bone Putty: Class I RecallPotential for this product to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery...
Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding PadsRecall due to the potential degradation of foil within the DGPHP grounding pad...
Hospira Propofol Injectable Emulsion: RecallRecall due to visible particles embedded in the glass to the user level...
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety CommunicationPhysicians should continue to closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead...
Covidien Shiley Adult Tracheostomy Tubes: Class I RecallRecall due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae...
Stryker Wingspan Stent System: Safety CommunicationThe indications for use and labeling for the Wingspan stent have changed to limit the use to a narrow, select group of patients and conditions...
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I RecallSystem errors may cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running...
Respironics, Inc., Trilogy 100, 200, and 202 Ventilators: Class I RecallDefective power supply components may cause unexpected cessation of function, thereby stopping ventilation of the patient...
B. Braun Infusomat Space Infusion System: Class I RecallPotential for breakage of the anti free flow clip catch located inside the infusion pump door...
CareFusion Alaris PC Unit, Model 8015: Class I RecallIf an error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy...
Benzalkonium Chloride Antiseptic Wipes by Dukal - RecallUse of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients...
Webinars and Educational Materials:I-Flow ON-Q Pump with ONDEMAND Bolus Button: Class I RecallBolus button may not lock in the down position when depressed and/or the orange bolus refill indicator may stay in the lowest most position...
Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I RecallIncorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions...
CareFusion Alaris Pump Module Model 8100: Class I RecallRecall due to reports of motor stalls during infusion with model 8100...
CareFusion 303, Alaris Pump Module, Model 8100: Class I RecallPump module door keypad overlay may become loose, peel away, or separate from the door assembly...
Synthes Hemostatic Bone Putty: Class I RecallPotential for this product to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery...
Covidien Initiates a Voluntary Recall of DGPHP RFA High-Power Single Use Grounding Pads and Cool-tip RFA Electrode Kits that Contain DGPHP RFA High-Power Single Use Grounding PadsRecall due to the potential degradation of foil within the DGPHP grounding pad...
Hospira Propofol Injectable Emulsion: RecallRecall due to visible particles embedded in the glass to the user level...
St. Jude Medical Riata Implantable Cardioverter Defibrillator (ICD) Leads: Safety CommunicationPhysicians should continue to closely monitor patients who have a Riata or Riata ST lead and notify patients if they have a recalled lead...
Covidien Shiley Adult Tracheostomy Tubes: Class I RecallRecall due to consumer complaints related to reports of volume leakage and/or disconnection between the inner and outer cannulae...
Stryker Wingspan Stent System: Safety CommunicationThe indications for use and labeling for the Wingspan stent have changed to limit the use to a narrow, select group of patients and conditions...
Smiths Medical Medfusion Model 4000 Syringe Infusion Pump: Class I RecallSystem errors may cause the Medfusion 4000 infusion pump to go into an alarm condition and stop running...
Respironics, Inc., Trilogy 100, 200, and 202 Ventilators: Class I RecallDefective power supply components may cause unexpected cessation of function, thereby stopping ventilation of the patient...
B. Braun Infusomat Space Infusion System: Class I RecallPotential for breakage of the anti free flow clip catch located inside the infusion pump door...
CareFusion Alaris PC Unit, Model 8015: Class I RecallIf an error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy...
Benzalkonium Chloride Antiseptic Wipes by Dukal - RecallUse of contaminated wipes could lead to infections, some of which pose health risks in immune-suppressed patients...
During this program, FDA analysts shared the types of reports received from engineers and why these reports are so valuable
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