FDA: Vascular Solutions recalls Venture Catheters
Editor's Note The Food and Drug Administration (FDA) on June 21 announced the recall by Vascular Solutions (Maple Grove, Minnesota) of its Venture Catheters. The recall was initiated because there is a risk of the catheter tip splitting or separating during use and entering the patient’s bloodstream. This can result…
FDA: Alvogen recalls seven lots of clindamycin
Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Alvogen/Hospira Inc, a Pfizer company, of seven lots of Clindamycin Injection USP ADD-Vantage Vials. The recall was initiated because microbial growth was detected during a routine simulation of the manufacturing process, which represents the potential…
FDA: Maquet/Datascope recalls certain Intra-Aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on June 19 announced the recall by Maquet/Datascope (Fairfield, New Jersey) of its System CS100, CS100i, and CS300 Intra-Aortic Balloon Pumps. The recall also applies to System 98 or System 98XT IABP that was converted to a CS100i or CS 300 IABP.…
FDA: Hospira recalls Sodium Bicarbonate, Quelicin, and Potassium Phosphates injections
Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Hospira, Inc, a Pfizer company, of the following: 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials 5 lots of Quelicin…
ECRI Institute announces release of CrossCHEQ
Editor's Note ECRI Institute on June 6 announced the release of CrossCHEQ, its new service that offers unbiased guidance on equivalent alternatives for medical-surgical supplies and implants. By comparing key performance indicators, buyers can assess opportunities for standardization and better respond when products are out of stock or recalled. The…
FDA: Class I recall of Zimmer Biomet implantable spinal fusion stimulators
Editor's Note The Food and Drug Administration (FDA) on May 30 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its SpF PLUS-Mini and SpF XL IIB implantable spinal fusion stimulators as Class I, the most serious. The recall was initiated because of higher than allowed levels of potential harmful…
FDA: Class I recall of HeartMate II LVAS Pocket System Controller
Editor's Note The Food and Drug Administration (FDA) on May 23 identified the recall by Abbott-Thoratec (Pleasanton, California) of its HeartMate II Left Ventricular Assist (LVAS) Pocket System Controller as Class I, the most serious. Abbott-Thoratec has receives 70 reports of incidents in which the controller malfunctions after an exchange,…
FDA: Class I recall of Wingman35 Crossing Catheters
Editor's Note The Food and Drug Administration on May 17 identified the recall by ReFlow Medical (San Clemente, California) of certain lots of its Wingman35 Crossing Catheters as Class I, the most serious. The catheters are being recalled because of tip splitting or separation that has resulted in two adverse…
FDA: Abbott recalls coronary catheters
Editor's Note The Food and Drug Administration on May 16 announced the recall by Abbott of specific lots of three coronary dilation and balloon catheters: NC Trek RX Coronary Dilation Catheter NC Traveler Coronary Dilation Catheter NC Tenku RX PTCA Balloon Catheter. The affected lots were manufactured between January 2015…
FDA: HeartWare VAD splice kit recalled
Editor's Note The Food and Drug Administration (FDA) on May 5 announced that Medtronic is recalling its splice kit used to repair the driveline of the HeartWare Ventricular Assist Device (VAD). The kit was recalled because of a design problem that prevents the repaired cable assembly from withstanding excessive force…
Free Daily News
- Study: Systemic gender bias embedded in surgical practice
- Literature review: Endoscope disinfection failures highlight need for stronger sterilization practices
- Study: GLP-1 drugs heighten risk of gastric residue but not perioperative pulmonary aspiration
- OAS CAHPS compliance soars to 96% among ASCs, vendor satisfaction also improves
- Knee surgical robot market set to surge, projected to reach $5.9B by 2032
- Health system mega-mergers fall short amid cost, quality concerns
- Health systems boost security spending as workplace violence escalates
- Strengthening healthcare cyber defenses challenged by third-party, asset-related risks
- Healthcare’s “Blockbuster Moment:” Dr Dan Weberg to deliver opening keynote address at OR Manager Conference
- Hospital staffing report: Nurse turnover eases but vacancies, costs remain high