FDA: Medtronic recalls battery pack for Capnostream 20, 20p monitors
Editor's Note The Food and Drug Administration announced on April 20 the recall by Medtronic of the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20 p patient monitors. Capnostream monitors are external devices used to assess a patient’s respiratory status. The recall was initiated because…
FDA: Pharmakon Pharmaceuticals recalls all sterile compounded products
Editor's Note The Food and Drug Administration (FDA) on April 20 announced that Pharmakon Pharmaceuticals (Noblesville, Indiana) issued a nationwide recall of all sterile compounded products because of a lack of sterility assurance and other quality issues. The sterile products were distributed between March 4 and April 15, 2016. …
FDA: Vascular Solutions recalls Guardian II hemostasis valves
Editor's Note The Food and Drug Administration (FDA) on April 11 announced the recall by Vascular Solutions, Inc (Minneapolis, Minnesota), of specific lots of Guardian II hemostasis valves used in catheterization procedures. The recall was initiated because of an increased risk of air leakage that may lead to an air…
FDA: Boston Scientific recalls Fetch 2 Aspiration Catheter
Editor's Note The Food and Drug Administration (FDA) on April 11 announced the recall by Boston Scientific (Marlborough, Massachusetts) of all models of its Fetch 2 Aspiration Catheter, a thrombectomy catheter used to remove small blood clots from coronary arteries. The recall was initiated because of complaints of shaft breakage…
FDA: B Braun Medical recalls one lot of 5% Dextrose Injection
Editor's Note The Food and Drug Administration on March 29 announced the recall by B Braun Medical (Bethlehem, Pennsylvania) of one lot of 5% Dextrose Injection USP 100/150 mL container (Lot #J5J706, catalog #S5104-5264, NDC -1510-32). The company received customer complaints that some containers exhibited leakage and, in a few…
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…
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