The FDA today published a warning letter it sent to epidural and anesthesia needle maker International Medical Development over issues with it marketing its Gertie Marx needles outside its indication and quality control issues related to manufacturing.
International Medical Development’s Gertie Marx needles are cleared for “the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter in adults,” according to the FDA.
The federal watchdog said the company is marketing the needles for lumbar puncture, myelogram and pediatric use, which it said the company lacks clearance or approval for.
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International Medical Development’s Gertie Marx needles are cleared for “the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter in adults,” according to the FDA.
The federal watchdog said the company is marketing the needles for lumbar puncture, myelogram and pediatric use, which it said the company lacks clearance or approval for.
Help employers find you! Check out all the jobs and post your resume.
