FDA

21 articles in the TruthFoundry index. Each links out to the original.

• FDA Alerts on Epidural Kits Containing Recalled Saline Ampules · FDA warns Medical Action Industries epidural kits may contain recalled saline ampules posing infection risks.
• FDA Issues Early Alert on Medline Breathing Circuit Heating Failures · FDA warns of potential heating failures in Medline neonatal breathing circuits that could damage patient airways.
• FDA Issues Early Alert on GE HealthCare Software Risk · FDA warns GE HealthCare Portrait devices may lose monitoring or alarms after software updates.
• Optimal Balance Pharmacy Recalls Glutathione Vials Over Endotoxin Risks · Optimal Balance Pharmacy voluntarily recalls specific lots of compounded glutathione due to elevated endotoxin levels.
• Medline Recalls Surgical Kits Due to B. Braun Anesthetic Component Issue · Medline issues a correction recall for surgical kits containing compromised B. Braun Bupivacaine Hydrochloride components.
• B. Braun Recalls Lactated Ringers Injection for Particulate Matter · B. Braun voluntarily recalls Excel Lactated Ringers Injection due to cotton and wood fibers posing embolism risks.
• FDA Issues Early Alert on BD Convenience Kits Due to Contaminated Saline · The FDA warns patients not to use certain Becton Dickinson convenience kits containing recalled saline ampules.
• FDA Classifies Becton Dickinson Intraosseous Needle Recall as Class I · Becton Dickinson recalled specific intraosseous needle sets due to manufacturing defects causing serious injuries and deaths.
• FDA Classifies Baxter Duo-Vent Solution Set Recall as Class I · FDA classifies Baxter's recall of Duo-Vent solution sets as a Class I due to air bubble risks.
• FDA Issues Early Alert on Medline Convenience Kits Due to BD Chloraprep Recall · FDA warns public to remove affected BD Chloraprep applicators from Medline convenience kits due to sterility breach risks.
• FDA Issues Class I Recall for Medline Convenience Kits Due to Huons Component · FDA classifies Medline recall of convenience kits as Class I due to compromised Huons Bupivacaine components.
• FDA Recalls Hamilton Medical Breathing Circuits Over Injury Risk · FDA classifies Hamilton Medical breathing circuit recall as Class I due to risk of serious injury or death.
• Abiomed and Oscor Issue Class I Recall for Catheter Introducer Leakage · Abiomed and Oscor issue a Class I recall for catheter introducers due to potential leakage causing bleeding.
• Medline Recalls Hudson RCI Heated Wire Breathing Circuits · Medline Industries recalls Hudson RCI breathing circuits due to potential thermal damage and smoke hazards.
• Fresenius Kabi Recalls Morphine Syringes Over Label Mix-Up · Fresenius Kabi voluntarily recalls one lot of Morphine Sulfate Injection due to a labeling error that could result in Dilaudid being dispensed.
• Victory Medical Center Recalls Glutathione Vials Over Endotoxin Levels · Victory Medical Center Pharmacy voluntarily recalls compounded glutathione vials due to elevated endotoxin levels.
• Liebel-Flarsheim Recalls OPTIRAY Contrast Agent for Particulate Matter · Liebel-Flarsheim Company recalls OPTIRAY 350 contrast agent due to plastic and metal particles.
• BD Recalls Intraosseous Needle Sets Due to Removal Difficulties · BD voluntarily recalls specific lots of Intraosseous Vascular Access System Needle Sets due to difficulty removing the obturator.
• American Regent Recalls Two Lots of Adequan Canine and Horse Injections Over Glass Fibers · American Regent Inc. recalls specific lots of Adequan injections for dogs and horses due to visible glass fiber contamination.
• FDA Classifies Medical Action Recall as Most Serious Type · FDA classifies a recall of Medical Action Industries kits containing defective manifolds as a Class I recall due to injury risk.
• Medline Recalls Convenience Kits Due to Huons Anesthetic Quality Issues · Medline issues correction for kits containing Huons lidocaine and bupivacaine due to FDA-identified quality issues.