FDA Warns Devicemakers Over Pen Needles

October 2, 2018

CDRH alerted device manufacturers about a post-market safety issue concerning pen needles used with pen injectors.

The hypodermic single lumen needles usually have an outer cover and a removable inner needle cover that are removed prior to injection. In some cases, the agency said, the inside cover is not removed before injection and the intended medication is not delivered.

The FDA urged manufacturers to clearly direct patients in their instructions for use to remove both the outer and inner covers.

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