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Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites and Interlink Injection Sites (2014-06-10)
- Starting date:
- June 10, 2014
- Posting date:
- July 7, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-40383
Recalled Products
A) Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites
B) Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites
Reason
Medtronic is initiating this voluntary recall because the patient line tubing in the duet? External drainage and monitoring systems may become disconnected from the patient line stopcock. Potential hazards that may occur as a result of a patient line disconnection are pneumocephalus, underdrainage, over drainage and infection.
Affected products
A) Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites
Lot or serial number
More than 10 lot numbers, contact manufacturer.
Model or catalog number
46914
46916
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES
B) Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites
Lot or serial number
More than 10 lot numbers, contact manufacturer.
Model or catalog number
46913
46915
46917
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES