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…
FDA announces AccessGUDID data update
Editor's Note The Food and Drug Administration announced that new data elements will be available on AccessGUDID, in the download files and in the APIs, as of April 2. Data for FDA Premarket Submission Number and FDA Premarket Supplement Number will not be provided until this summer. The FDA is…
FDA: Class I recall of BD Vacutainer® blood collection tubes
Author's Note The Food & Drug Administration on March 23 announced the Class I recall of Becton Dickinson (BD) Vacutainer® EDTA (ethylenediaminetetraacetic acid) blood collection tubes with lavender, tan, pink, and green rubber tube stoppers. Class I recalls are the most serious. The recall was initiated because of a chemical…
FDA: Potential for increased image artifact when using MRA for follow-up of embolization coil procedures
Editor's Note The Food & Drug Administration (FDA) on March 12 issued a Safety Alert on the potential for increased artifact associated with magnetic resonance angiography (MRA) imaging for follow-up of certain post neurovascular embolization coil procedures. When MRA is performed on patients implanted with neurovascular embolization coils containing 304V…
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