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…
FDA: Medtronic recalls battery pack used on patient monitors because of fire risk
Editor's Note The Food and Drug Administration (FDA) on May 27 classified the recall by Medtronic of its Capnostream 20 and Capnostream 20p patient monitor battery packs as Class I, the most serious. The recall is being initiated because a manufacturing defect causes an increase in temperature in the battery…
ECRI Institute releases new equipment recall management tool
Editor's Note ECRI Institute (Plymouth Meeting, Pennsylvania) on May 23 released its new recall management tool, Automatch for Equipment. The tool automatically identifies equipment models and supplies in a healthcare facility’s inventory that are impacted by an alert or recall, and notifies designated department staff. Automatch for Equipment is the…
FDA: Recall of Well Care Compounding Pharmacy sterile products in Nevada
Editor's Note The Food and Drug Administration (FDA) on May 18 announced the recall by Well Care Compounding Pharmacy of all sterile compounded products because of concern over lack of sterility assurance. The recall is for Nevada and impacts all sterile compounded products distributed between January 1 and April 29,…
FDA drops recall of Custom Ultrasonics’ System 83 Plus endoscope reprocessor
Editor's Note The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports. The FDA…
FDA: Cook recalls all Beacon Tip catheters
Editor's Note The Food and Drug Administration (FDA) on May 4 announced the recall by Cook Medical (Bloomington, Indiana) of all lots of its catheters with Beacon Tip technology. The catheters are used in angiographic, radiographic, interventional, and urologic procedures. The catheters have been found to exhibit polymer degradation of the…
FDA: Fresenius Kabi USA recalls one lot of Sensorcaine-MPF (bupivacaine HCL)
Editor's Note The Food and Drug Administration (FDA) on April 26 announced the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of one lot of Sensorcaine-MPF (bupivacaine HCL) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall was initiated because of the presence of…
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