FDAFDA · Food and drugs·Recall number Z-1923-2014
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. 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. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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