FDA: Class I recall of Merit Medical’s sheath introducer
Editor's Note The Food and Drug Administration (FDA) on March 31 labeled Merit Medical Systems' (South Jordan, Utah) recall of the Prelude Short Sheath Introducer as Class I, the most serious. The recall was issued because of a manufacturing defect that may cause the tip to separate from the sheath…
FDA: Field corrective action for Medtronic’s Newport HT70, HT70 Plus ventilators
Editor's Note On April 5, the Food and Drug Administration (FDA) announced that Medtronic (Minneapolis) has notified its customers of a field corrective action for all Newport HT70 and Newport HT70 Plus ventilators manufactured since 2010. The field corrective action is being conducted after reports that the ventilator may reset…
FDA: Class I recall of HeartStart MRx Monitoy/Defibrillator
Editor's Note The Food and Drug Administration (FDA) on March 24 identified the recall of the HeartStart MRx Monitor/Defibrillator by Phillips Healthcare (Amsterdam) as Class I, the most serious. The recall was initiated because of electrical and battery connection issues that may prevent the device from powering up, charging, and…
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: 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…
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: Hospira recalls one lot of Vancomycin Hydrochloride for Injection
Editor's Note The Food and Drug Administration (FDA) on January 25 announced the recall by Hospira, Inc (Lake Forest, Illinois) of one lot of Vancomycin Hydrochloride for Injection, (USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017). The recall was initiated because of a confirmed customer report of the presence of…
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