FDA

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

• B. Braun recalls three lots of saline injection due to particulate matter · B. Braun Medical Inc. recalled three lots of saline injection due to particulate matter.
• FDA Recalls GE HealthCare Software Due to Patient Monitoring Risks · FDA classifies GE HealthCare software recall as Class II due to potential loss of patient monitoring and alarm resets.
• FDA Issues Early Alert on Draeger VentStar Resus Neo Hose Defects · FDA warns of potential patient death risk from cracked or detached hoses in Draeger VentStar Resus Neo breathing circuits.
• Boston Scientific Recalls Infinion CX Leads Over Injury Risk · Boston Scientific recalls unused Infinion CX Spinal Cord Stimulator leads due to fracture risk causing serious injuries.
• FDA: Medline corrects convenience kits with BD ChloraPrep applicators over sterility risk · FDA reports Medline correction of convenience kits containing BD ChloraPrep applicators due to potential sterility breach.
• FDA Classifies Medline Catheter Recall as Most Serious Type · Medline Industries recalls reprocessed catheters due to particulate risks; FDA classifies it as Class I.
• Medline Recalls Neonatal Heated Wire Breathing Circuits Due to Electrical Failures · Medline recalls neonatal and infant heated wire breathing circuits due to electrical connector failures that may cause health problems.
• FDA Issues Early Alert on Avid Medical IV Start Kits Over Fungal Contamination Risk · FDA warns Avid Medical IV Start Kits with recalled BD ChloraPrep applicators may be contaminated and should be destroyed.
• FDA Issues Early Alert on Boston Scientific Imager II Catheter Recall · FDA warns of Boston Scientific Imager II catheter recall over tip degradation risk.
• FDA Issues Class I Recall for AVID Medical Kits with Contaminated Manifolds · FDA issues Class I recall for AVID Medical convenience kits containing Medline manifolds with particulate contamination risks.
• FDA Issues Alert on Medtronic Esophageal pH Monitoring Device Defects · FDA warns of Medtronic Bravo CF device failures causing serious patient injuries.
• FDA Issues Early Alert on Abiomed Impella Controller Purge Flag Failures · FDA alerts on Abiomed Automated Impella Controller purge flag failures, recommending removal and replacement.
• FDA Classifies Boston Scientific ENROUTE Catheter Recall as Class I · FDA classifies Boston Scientific's recall of the ENROUTE Transcarotid Neuroprotection System as a Class I recall due to injury risk.
• Baxter Recalls Sodium Citrate Solution Over Fiberglass Particulate Risk · Baxter International voluntarily recalls one lot of anticoagulant solution due to potential fiberglass contamination.
• Baxter Recalls One Lot of 70% Dextrose Injection Over Stainless Steel Particles · Baxter International Inc. voluntarily recalled one lot of 70% Dextrose Injection after finding potential stainless steel particles.
• Baxter Recalls Two Lots of Sodium Chloride Injection Over Fiberglass Particulate Risk · Baxter International Inc. voluntarily recalled two lots of 0.9% Sodium Chloride Injection due to potential fiberglass particulate matter.
• FDA Issues Early Alert on CooperSurgical Ventilator Connection Risk · FDA warns CooperSurgical ventilators may have loose connections risking patient oxygenation.
• FDA Issues Early Alert on Medline Convenience Kits Due to Fungal Contamination Risk · FDA warns public to destroy Medline convenience kits containing recalled BD ChloraPrep applicators due to potential fungal contamination.
• FDA Issues Early Alert on AVID Medical Kits Due to Fungal Contamination Risk · FDA warns public to quarantine and destroy AVID Medical convenience kits due to potential fungal contamination.
• FDA Issues Early Alert on NOxBOX Nitric Oxide Device Leak Risk · FDA warns of potential oxygen leaks in NOxBOXi devices that could interrupt nitric oxide therapy.
• Vitruvias Therapeutics Recalls Thyroid Tablets for Superpotency Risk · Vitruvias Therapeutics voluntarily recalls one lot of Thyroid Tablets due to confirmed superpotency.
• FDA Issues Early Alert on Epidural Kits Contaminated by Recalled Saline · FDA warns medical facilities to quarantine epidural kits containing saline ampules from a recalled manufacturer.
• FDA Issues Early Alert on GE HealthCare Portrait Software Risk · FDA warns GE HealthCare Portrait devices may lose monitoring or alarms after software updates.
• 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.
• 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.
• Optimal Balance Pharmacy Recalls Glutathione Vials Over Endotoxin Levels · Optimal Balance Pharmacy voluntarily recalls compounded glutathione vials due to elevated endotoxin levels.
• B. Braun Recalls Lactated Ringers Injection Over Particulate Matter · B. Braun voluntarily recalls a lot of Excel Lactated Ringers Injection due to cellulose and polystyrene particles.
• 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.