FDA: Vascular Solutions recalls Twin-Pass Dual Access Catheters
Editor's Note The Food and Drug Administration on October 5 announced the recall by Vascular Solutions, Inc, (Minneapolis, Minnesota) of its Twin-Pass Dual Access Catheters used in catheterization procedures. The catheters have been recalled because of the potential for excess manufacturing material to remain at the tip of the catheter…
FDA: Recall of Baxter 50 mm 0.2 micron filters
Editor's Note The Food and Drug Administration on October 3 announced the recall by Baxter International (Deerfield, Illinois) of its 50 mm 0.2 micron filters because of the potential for a missing filter support membrane and for potential presence of particulate matter. The filter is a bacteria and particulate filter…
FDA: Class I recall of DePuy Synthes power tool system battery adaptors
Editor's Note The Food and Drug Administration (FDA) on September 28 identified the recall by DePuy Synthes (a Johnson & Johnson company) of its Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II as Class I, the most serious. The recall is due to the potential…
FDA classifies recall of Roadrunner UniGlide Hydrophilic Wire Guides as Class I
Editor's Note The Food and Drug Administration (FDA) on September 6 classified the recall of the Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical (Bloomington, Indiana) as Class I, the most serious. All serial and lot numbers are being recalled, and the product line is being discontinued because of concern…
FDA: Sagent Pharmaceuticals recalls one lot of Oxacillin for Injection
Editor's Note The Food and Drug Administration (FDA) on August 19 announced the recall by Sagent Pharmaceuticals, Inc (Schaumburg, Illinois), of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp Date March 2017). The recall was initiated because of a user complaint of a vial…
FDA issues safety alert on Custom Ultrasonics reprocessors
Editor's Note The Food and Drug Administration (FDA) on August 17 issued a Safety Alert on the System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics (Warminster, Pennsylvania), recommending that healthcare facilities stop using them to reprocess duodenoscopes. The system may still be used for reprocessing endoscopes other than duodenoscopes.…
FDA: Cook Medical recalls Roadrunner UniGlide Hydrophilic Wire Guides
Editor's Note The Food and Drug Administration (FDA) on August 15 announced the recall by Cook Medical (Bloomington, Indiana) of 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because of concerns about a potential contamination of the wires’ hydrophilic coating with glass particles. The wire guides are used in…
FDA: Hospira recalls one lot of 0.25% Bupivacaine Hydrochloride Injection
Editor's Note The Food and Drug Administration (FDA) on August 5 reported that Hospira, Inc (Lake Forest, Illinois) is recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064-DK, Expiry 1 Nov 2017) because of the presence of particulate matter found in a single vial. The lot…
FDA: Class I recall of Stryker’s Angiodynamics Soft Vu Omni Flush Angiographic Catheters
Editor's Note The Food and Drug Administration (FDA) on July 22 categorized the recall of Stryker Sustainability Solutions' (Tempe, Arizona) Angiodynamics Soft Vu Omni Flush Angiographic Catheters as Class I, the most serious. The recall was issued because of reports of separation of the catheter tip from the main body.…
FDA: Class I recall of HeartWare Ventricular Assist Device batteries
Editor's Note The Food and Drug Administration (FDA) on June 29 categorized the recall of HeartWare Ventricular Assist Device (HVAD) batteries by HeartWare Inc (Framingham, Massachusetts) as Class I, the most serious. The batteries are being recalled because they may lose power prematurely because of faulty cells. If the HVAD…
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