fda Archives - Page 17 of 18 - In Compliance Magazine

Angiographic Catheters Recalled

Cook Medical of Bloomington, IN has announced the recall of nearly 100,000 of the company’s angiographic catheters for problems related to catheter tip splitting or separation. According to a press release p... Read More...

FDA’s CDRH Seeking Customer Feedback

The U.S. federal agency responsible for the regulation and oversight of medical devices is seeking comments on the quality of its customer service to industry. The Center for Devices and Radiological Health ... Read More...

Medical Device Cybersecurity Guidelines Released

The Food and Drug Administration has announced guidelines for cybersecurity for medical device manufacturers. The guidelines recommend that manufacturers consider possible cybersecurity issues, and solution... Read More...

Recalled Medical Product Lacked FDA 510(k) Approval

In conjunction with the U.S. Food and Drug Administration (FDA), ConvaTec, Inc. has initiated a recall of its Flexi-Seal CONTROL-brand fecal management systems. Fecal management systems are temporary containmen... Read More...

Playtex AC/DC Breast Pump Recall | In Compliance Magazine

Voluntary Recall of Breast Pump AC/DC Power Adapters Expanded

Playtex Manufacturing, Inc. added a production lot to a March 2014 voluntary recall of AC/DC power adapters used with Playtex® Nurser Deluxe Double Electric Breast Pump. The recall was issued because casing on ... Read More...

TIA Commends New FDA Approach to Medical Device Data Systems

The Telecommunications Industry Association (TIA) submitted comments to the Food and Drug Administration (FDA) in support of its new approach to medical device data systems (MDDS) devices, medical image stori... Read More...

GEHealthcare Recall | In Compliance Magazine

Medical CO2 Detectors Recalled

GE Healthcare, LLC, of Waukesha, WI has issued a recall of certain models of the company’s single-width airway modules and accessories used in hospitals and other healthcare facilities for monitoring CO2 and re... Read More...

Infusion Pump Manufacturer Announces Corrective Action

Hospira, Inc. of Lake Forest, IL has issued an urgent correction notice in connection with a docking station used with the company’s GemStar infusion pumps. In a press release issued by the company and poste... Read More...

Medical Devices | In Compliance Magazine

Medical Device Recalls Double in Past Decade

The number of recalls of defective medical devices has nearly doubled within a ten year period, according to data compiled by the U.S. Food and Drug Administration (FDA). As reported by the Wall Street Journ... Read More...

New Medical Device Available to Prevent Migraine Headaches

The U.S. FDA has approved the first device as a preventative treatment for migraine headaches. The device is a small, portable, battery-powered device that looks similar to a plastic headband that is worn across the forehead and on top of the ears prior to the onset of pain.

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