FDA sends letter to healthcare providers on neurovascular stents
Editor's Note The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms. The FDA has received reports associated with these devices that suggest events of peri-procedural…
FDA: AuroMedics recalls two lots of Ampicillin and Sulbactam for Injection
Editor's Note The Food and Drug Administration (FDA) on May 8 announced the recall by AuroMedics Pharma (Windsor, New Jersey) of two lots of Ampicillin and Sulbactam for Injection USP, 3 g single-dose vials. The recall was issued because of customer complaints of the presence of red particulate matter in…
FDA issues Safety Alert for magnetic resonance-guided laser interstitial thermal therapy devices
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Alert that provides preliminary information concerning magnetic resonance (MR) thermometry reliability with MR-guided laser interstitial thermal therapy (MRgLITT) devices. The FDA is evaluating data that suggests potentially inaccurate MR thermometry information can be displayed during treatment,…
FDA issues letter to healthcare providers on risks of endoscope connectors
Editor's Note The Food and Drug Administration (FDA) on April 18 alerted healthcare providers and facilities about the risk of cross-contamination with 24-hour, multipatient use connectors used in gastrointestinal (GI) endoscopy. Endoscope connectors are small accessories used to connect the auxiliary water channel to a water source and irrigation tubing.…
FDA approves firmware update for Abbott ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on April 17 announced that it had approved a firmware update that is now available for certain Abbott (formerly St Jude Medical) implantable cardiac devices (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The update is a corrective action (recall) to reduce the…
FDA alert: Coastal Meds recalls all sterile products
Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Coastal Meds (Biloxi, Mississippi) of all nonexpired products marketed as sterile because of visible particles in some of the drug vials for injection and poor sterile production practices. The FDA on April 5 requested the…
FDA: Premier Pharmacy Labs recalls certain sterile injectable products
Editor's Note The Food and Drug Administration (FDA) on April 12 announced the recall by Premier Pharmacy Labs (Weeki Wachee, Florida) of certain lots of sterile injectable products because of a potential lack of sterility assurance. The products include morphine sulfate (2 mg/mL and 3 mg/mL), hydromorphone HCL 1 mg/mL,…
FDA: Recall of Acrodose Plus and PL systems by Haemonetics
Editor's Note The Food and Drug Administration (FDA) on April 13 announced the recall by Haemonetics (Braintree, Massachusetts) of certain lots of its Acrodose Plus and PL Systems because the company has received reports of low pH readings for platelets stored in CLX HP bags. In some instances the drop…
Hysterectomy complication rates after FDA warning against power morcellation
Editor's Note In this study, 30-day complications rates increased after the Food and Drug Administration (FDA) warned against the use of power morcellation in women undergoing hysterectomy for benign gynecologic indications. In a cohort of 75,487 women who had hysterectomies, statistically and clinically significant increases in major (1.9% to 2.4%)…
FDA: System 83 Plus AERs complete validation testing
Editor's Note The Food and Drug Administration (FDA) on April 10 notified healthcare facilities that Custom Ultrasonics (Ivyland, Pennsylvania) has completed validation testing of the System 83 Plus (ie, System 83 Plus, System 83 Plus 2, and System 83 Plus 9) automated endoscope reprocessors (AERs) with specific duodenoscopes. The FDA…
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