FDA: Cardinal Health recalls Monoject Saline Flush Prefilled Syringes
Editors Note The Food and Drug Administration (FDA) on August 23 identified the recall by Cardinal Health of its Monoject Saline Flush Prefilled Syringes as Class I, the most serious. Cardinal Health is recalling three models of the syringes because the syringe plunger may pull air into the syringe after…
ECRI partners with Nuvolo on standardization of device data
Editor's Note ECRI on July 20 announced a collaborative partnership with Nuvolo, an independent software vendor involved in cloud-based connected workplace solutions, based in Paramus, New Jersey. The partnership integrates ECRI’s standardization of medical device data with Nuvolo’s Connected Workplace for Healthcare. This automated process enables standardization of device data…
FDA: Class I recall of Medtronic angiographic guidewire
Editor's Note The Food and Drug Administration (FDA) on July 2 identified the recall by Medtronic Vascular of its angiographic guidewire component as Class I, the most serious. The recall was initiated because the devices were not sterilized before being shipped to hospitals. The guidewire is used during angiography or other interventional…
FDA: Class I recall of Avid Medical convenience kits
Editor's Note The Food and Drug Administration on June 25 identified the recall by Avid Medical of its convenience kits for medical-surgical procedures as Class I, the most serious. The company is recalling those kits that contain BD/Carefusion’s Chloraprep 3 mL applicator because of the risk of contamination of the…
FDA: Class I recall of DeRoyal surgical procedure packs
Editor's Note The Food and Drug Administration (FDA), on June 25, identified the recall of DeRoyal Industries’ surgical procedure packs as Class I, the most serious. The recall was initiated because the packs contain 1% lidocaine that had been mislabeled as 0.5% bupivacaine. The procedure packs are used for cardiac…
FDA: Class I recall of Boston Scientific’s VICI, VICI RDS Venous Stent systems
Editor's Note The Food and Drug Administration (FDA), on May 21, identified the recall by Boston Scientific Corporation of its VICI Venous Stent and VICI RDS Venous Stent systems as Class I, the most serious. The recall was initiated because of reports that the stents may migrate or move from…
FDA: BD recalls certain lots of ChloraPrep
Editor's Note The Food & Drug Administration announced on April 20 that Becton, Dickinson and Company (BD) was recalling certain lots of its ChloraPrep Hi-Lite Orange 26 mL Applicator. ChloraPrep is used as an antiseptic to prepare a patient’s skin before surgery. The recall was initiated because the Applicator, which…
Hospira recalls one lot each of 0.5% Bupivacaine and 1% Lidocaine because of mislabeling
Editor's Note Hospira Inc, a Pfizer company, announced May 4 that it is recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCL Injection, USP 30 mL because of mislabeling. A portion of each lot was incorrectly labeled as the other product.…
FDA: Class I recall of Alaris Infusion Pump Module 8100
Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…
FDA: Class I recall of Cordis Precise PRO Rx US Carotid System
Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…
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