America’s Unsafe Drugs and Medical Products

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Microbiological Contamination in Topical Anesthetic Used Before Applying a Tattoo
> Issue date: August 8, 2019
> Type of alert: Recall

Ridge Properties DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products following an FDA analysis that found both microbiological contamination and higher-than-labeled potency.

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Endotracheal Tube Connection May Fail
> Issue date: August 8, 2019
> Type of alert: Recall

Teleflex has informed Centurion of a recall of selected Sheridan Endotracheal Tubes and Connectors included in a kit. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” Teleflex has received reports of four deaths and 18 injuries related to the recalled devices.

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Treatment of Peripheral Arterial Disease With Balloons and Stents That Increase Mortality Risk
> Issue date: August 7, 2019
> Type of alert: Letter to health care providers

The FDA has reported that devices such as balloons and stents coated with paclitaxel raised the mortality risk for patients five years after being treated with the device by 57%. The report follows a January letter notifying health care providers of increased risk after two years and a March update noting an increased risk of mortality in five years.

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Electrical Failure in Implantable Cardioverter Defibrillators
> Issue date: August 5, 2019
> Type of alert: Recall

Abbot (formerly St. Jude Medical) is recalling 108 Ellipse Implantable Cardioverter Defibrillators that have a manufacturing flaw in the wire leads that could lead to an electrical short. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.” The devices were manufactured between April 5 and May 29 of this year and distributed between May 6 and June 14.

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Potential Leak in Pipette Filters
> Issue date: August 2, 2019
> Type of alert: Recall

A manufacturing problem has led to the recall of nearly 1.3 million filter-tips for the Qiagen QIAsymphony SP/AS instruments used in clinical assay workflows or with in vitro diagnostic tests. The flawed filter-tips may yield delayed or inaccurate results, including false positives, false negatives or incorrect counts. This is a Class I recall, an FDA category for the most serious type of recall, indicating that the device “may cause serious injury or death.”