FDA: Class I recall of Medtronic implantable drug infusion pumps
Editor's Note The Food and Drug Administration (FDA) on March 14 categorized the recall by Medtronic (Minneapolis) of its SynchroMed II and SynchroMed EL implantable drug infusion pumps as Class I, the most serious. The pumps are being recalled because a software problem may cause unintended delivery of drugs during…
FDA issues alert on use of angioplasty devices in TVAM
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a Safety Alert about the use of balloon angioplasty devices to perform an experimental procedure, called transvascular autonomic modulation (TVAM). TVAM consists of threading a catheter into a patient’s venous system, such as the jugular vein, where a…
Joint Commission evaluating use of non-powdered gloves
Editor's Note As a result of the Food and Drug Administration’s ban on powdered gloves that went into effect January 18, the Joint Commission is now evaluating organizations on the implementation of non-powdered glove use during accreditation surveys, the Joint Commission announced March 7. Instances of noncompliance are being cited…
FDA: Avella recalling injectable products labeled ‘latex free’
Editor's Note The Food and Drug Administration (FDA) on February 24 announced that Avella Specialty Pharmacy of Houston is recalling all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma’s Houston location between September 1, 2016 and February 16, 2017. Avella and Advanced Pharma have been…
FDA: Class I recall of Zimmer Biomet Comprehensive Reverse Shoulder
Editor's Note The Food and Drug Administration (FDA) has categorized the recall by Zimmer Biomet (Warsaw, Indiana) of its Comprehensive Reverse Shoulder as Class I, the most serious. The recall was issued because the devices are fracturing at a higher rate than is stated in the labeling. Fractures may result…
Joint Commission checking for compliance with FDA powdered gloves ban
Editor's Note The Joint Commission announced February 15 that it will now evaluate all accredited organizations for compliance with the January 18 Food and Drug Administration (FDA) ban on powdered gloves. Citations will be listed under Leadership (LD) 04.01.01 element of performance (EP) 2: “The organization provides care, treatment and…
Gaps in FDA’s adverse event reporting system allowed power morcellator risks
Editor's Note A Government Accountability Office (GAO) report finds that gaps in the Food and Drug Administration’s (FDA’s) adverse event reporting system allowed the widespread use of laparoscopic power morcellators for years before their risk for spreading cancer became known, according to the February 10 Mass Device. Immediate Congressional action…
FDA: Class I recall of CareFusion Alaris Syringe Pump
Editor's Note The Food and Drug Administration (FDA) on February 9 classified the recall by CareFusion (San Diego) of its Alaris Syringe Pump (large volume pump), model 8100, and air-in-line (AIL) sensor kits as Class I, the most serious. The recall was issued because of a faulty AIL sensor, which…
FDA: Class I recall of Bard Halo One Thin-Walled Guiding Sheath
Editor's Note The Food and Drug Administration (FDA) on January 30 classified the recall by Bard Peripheral Vascular Inc (Tempe, Arizona) of its Halo One Thin-Walled Guiding Sheath as Class I, the most serious. The recall was issued because the sheath body may separate from the sheath hub while removing…
FDA warns of allergic reactions to CHG
Editor's Note The Food and Drug Administration (FDA) on February 2 issued a warning that rare but serious allergic reactions have been reported with use of chlorhexidine gluconate (CHG). The FDA is requesting that manufacturers add a warning label about this risk to over-the-counter (OTC) products containing CHG. CHG is…
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