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Penumbra catheter recall

This article was originally published in The Gray Sheet

Executive Summary

Firm is recalling older revisions of its Neuron 6F 070 delivery catheter after receiving reports that it could kink or ovalize in certain anatomy, leading to difficulty advancing the catheter or using it to deliver other devices. Consumers with the older Neuron 6F catheters should return them to receive a replacement, Penumbra says Sept. 29. In May, Penumbra recalled nine Neuron 5F Select catheters in a Class 1 action related to pinholes and exposed wire braids (1"The Gray Sheet" Sept. 14, 2009)

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Swissmedic Clears Up Confusion Over Validity Of GMP Certificates

Swissmedic says its good manufacturing practice certificates remain valid for longer than companies might assume. Separately, it is giving companies more time to conduct nitrosamine-related risk evaluations.





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