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MedWatch Safety Alerts

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FDA MedWatch Safety Alerts

Potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.
Posted: September 28, 2016, 6:40 pm
Administration of a drug product intended to be sterile that has microbial contamination may result in infections that may be serious and life-threatening.
Posted: September 22, 2016, 6:50 pm
Adverse event reports involving hallucinations, stroke-like symptoms, confusion, dizziness, blurred vision, dry mouth, slurred speech, imbalance, and disorientation.
Posted: September 15, 2016, 3:20 pm
Affected product with detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal.
Posted: September 9, 2016, 6:07 pm
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Posted: September 8, 2016, 12:20 pm
Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Posted: September 7, 2016, 9:17 pm
Using unproven ovarian cancer screening tests may be harmful for women with increased risk for developing ovarian cancer.
Posted: September 7, 2016, 6:40 pm
UPDATED 09/06/2016 Recall classified as Class I. Recalled Device and Discontinuation of the Product line
Posted: September 6, 2016, 8:40 pm
Health care professionals may make inaccurate clinical diagnoses or inaccurate medical treatment decisions for patients by relying on incorrect results from the devices, which may lead to serious adverse health consequences.
Posted: September 1, 2016, 4:40 pm
Reports of intraoperative or postoperative bleeding and hematomas, some of which required additional intervention, and three patient deaths potentially related to this issue that occurred shortly after carotid endarterectomy surgery.
Posted: September 1, 2016, 1:00 pm
Combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system has resulted in serious side effects, including slowed or difficult breathing and deaths.
Posted: August 31, 2016, 4:01 pm
UPDATED 08/30/2016. Company press release with additional information added. Recall expanded to include all lots of DHZC-2 tablets.
Posted: August 30, 2016, 8:30 pm
Patients could take less than their intended lamotrigine dose, which may lead to reduced therapeutic effects of lamotrigine and reemergence of epilepsy or bipolar disorder symptoms.
Posted: August 29, 2016, 7:17 pm
Reports of serious clinical consequences, such as over- and under- infusion of high risk or life-sustaining medications, occlusion detection failures, inadvertent boluses caused by inconsistent fluid delivery, and other malfunctions.
Posted: August 25, 2016, 4:00 pm
Klebsiella pneumoniae contamination, if present in the product, may result in infections that may be sight-threatening.
Posted: August 22, 2016, 3:45 pm
Administered of metal particulate may result in serious adverse events such as stroke, heart attack, respiratory failure, kidney failure, or liver failure.
Posted: August 19, 2016, 5:00 pm
Risk of sub-therapeutic dose as well as potential microbial contamination.
Posted: August 18, 2016, 6:20 pm
UPDATED 8/16/2016. Recall expanded to include an additional lot. Product with B. cepacia may cause serious, life-threatening infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups.
Posted: August 17, 2016, 6:15 pm
Health care facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Posted: August 17, 2016, 1:30 pm
The detection problem could lead to a risk of false negative or invalid results for clinical laboratory tests. The use of the affected product may cause serious adverse health consequences, including death.
Posted: August 12, 2016, 11:20 pm