Medtronic Duet External Drainage and Monitoring System recall
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage…
Why was Medtronic Duet External Drainage and Monitoring System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No. 206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202
- Product
- Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage…
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 1,187 units
- Distribution
- 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.
- Recall date
- July 9, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)