FDAFDA · Food and drugs·Recall number Z-1920-2014
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Published July 9, 2014 · Recall initiated: June 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Neurosurgery
- Distributor
- Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
- Lot
- Lot No. 206923217 207096627 207096630 207187691 207224897 207269986 207466017 207565424 207565425 207659575 207659576 207739874 207875274 207945037 207982847
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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