QMED

7 Recent Medical Device Failures Catching FDA’s Eye

BOTW-50w Source:  QMED – Qualified Suppliers to the Medical Device Industry

“The FDA last month designated a Medline Industries guidewires recall as Class I.

The Medline guidewire is identified as the ACME Monaco Guidewire .035×150 3MMJ TCFC item number 88241, with affected products distributed between March 2013 and August 2013.

The guidewire is used in various surgical convenience kits assembled and marketed by Medline Industries. It is meant to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

The guidewires in question, however, have the potential for the coating to flake off of the wire, according to the FDA.”

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Plastics and Metals Team Up in Medical Device Apps

BOTW-50w Source:  MPMN Medtec Pulse

“… to be able to deliver devices with ever-increasing performance levels, medical device manufacturers continue to face many design challenges and requirements. Propelling these requirements is the unrelenting trend toward minimally invasive procedures, requiring smaller and smaller devices made from a range of microcomponents, and the trend toward increasing medical device connectivity. As a result, there is a growing need to unite plastics and such metals as stainless steel, although they used to be fierce competitors.”

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