FDA: All compounded products by Reliable Drug Pharmacy recalled
Editor's Note The Food and Drug Administration (FDA) on March 28 announced that Reliable Drug Pharmacy (San Francisco, California) is recalling all unexpired lots of compounded products because of concerns of lack of quality assurance and potential mislabeling. The recall affects all compounded products distributed between March 24, 2015 and…
FDA: Hospira recalls one lot of Sodium Bicarbonate Injection
Editor's Note The Food and Drug Administration (FDA) on March 21 announced the recall by Hospira, Inc (Lake Forest, Illinois) of one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry August 1, 2017). The recall was initiated because of the presence of a particulate in a single-dose…
FDA: Class I recall of GlideScope Titanium Single-Use Video Laryngoscope
Editor's Note The Food and Drug Administration (FDA) on March 18 announced the Class I recall of the GlideScope Titanium Single-Use Video Laryngoscope by Verathon (Bothell, Washington). Class I is the most serious. The recall was initiated because of a potential disruption in the video feed from the laryngoscope blade…
FDA: Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
Editor's Note The Food and Drug Administration (FDA) on March 11 announced the Class I recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated (Wayne, Pennsylvania). Class I is the FDA’s most serious recall classification. The Kits are being recalled because the sheath body…
FDA: Abbott issues safety notice for MitraClip Delivery System
Editor's Note The Food and Drug Administration on February 29 announced a safety notice issued by Abbott (Abbott Park, Illinois) to reinforce the proper procedures used to operate and deploy its MitraClip Delivery System. The company has received nine reports of device malfunction where the user was unable to separate…
FDA: Facilities should transition from Custom Ultrasonics endoscope reprocessors
Editor's Note The Food and Drug Administration (FDA) on February 23 updated its Safety Communication on the November 2015 recall of Custom Ultrasonics automated endoscope reprocessors. The update recommends that healthcare facilities transition to alternative methods to reprocess flexible endoscopes as soon as possible. In November, the FDA cited violations…
FDA: Baxter recalls one lot of 0.9% Sodium Chloride Solution for Irrigation
Editor's Note The Food and Drug Administration on February 18 announced the recall by Baxter (Deerfield, Illinois) of one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL, plastic pour bottle solution—Lot G120162, expiration 11/30/2018. The solution is being recalled because of a customer complaint of the presence of particulate…
FDA: Class I recall of Drager Oxylog Emergency Transport Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 10 classified the recall of the Oxylog 2000 Plus, 3000, and 3000 plus Emergency Transport Ventilators by Drager Medical (Telford, Pennsylvania) as Class I, the most serious. The recall was initiated because of an electrical issue that may cause the…
FDA: Cook recalls Central Venous Catheters and Pressure Monitoring Sets and Trays
Editor's Note The Food and Drug Administration (FDA) on February 11 announced that Cook Medical (Bloomington, Indiana) initiated a recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays because of the potential for catheter tip fracture or separation. The products were distributed…
FDA: Class I recall of Optisure Dual Coil Defibrillation Leads
Editor's Note The Food and Drug Administration (FDA) on January 27 classified the recall of St Jude Medical’s (St Paul, Minnesota) Optisure Dual Coil Defibrillation Leads as Class I, the most serious. The recall was initiated because of a manufacturing error that may have damaged the insulation layer of one…
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