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 proposes ban on most powdered gloves
Editor's Note The Food and Drug Administration (FDA) on March 21 announced a proposal to ban most powdered gloves in the US. The proposed ban applies to powdered surgeons' gloves, powdered patient examination gloves, and absorbable powder for lubricating surgeons' gloves. Powdered gloves pose an unreasonable and substantial risk of…
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: Reprocessing instructions validated for Olympus duodenoscope models TJF-160F and TJF-160VF
Editor's Note The Food and Drug Administration (FDA) on March 15 announced that Olympus (Center Valley, Pennsylvania) has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160 VF duodenoscope models to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the…
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 warns about magnetic interference between breast tissue expanders and ICDs, pacemakers
Editor's Note The Food and Drug Administration (FDA) on March 8 issued a warning about magnetic interference between breast tissue expanders with magnetic ports and implantable cardioverter-defibrillators (ICDs) or pacemakers in patients. The breast expanders can interfere with the functioning of these cardiac devices, causing them to go into "magnet…
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