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CSF-Unitized Shunt, Contoured Regular, Low Pressure and Medium Pressure (2013-11-19)
- Starting date:
- November 19, 2013
- Posting date:
- January 13, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-37461
Recalled products
- CSF-Unitized Shunt, Contoured Regular, Low Pressure and Medium Pressure
Reason
The unitized shunts had label dimensions that indicated the ventricular catheter lengths were 11 cm instead of 13 cm and that the peritoneal catheter lengths were 65 cm instead of 90 cm in length. Medtronic investigation confirms that it is limited to the lot numbers listed and this may be a physician nuisance but potential risk is remote. There have been no reported adverse effects concerning this condition.
Affected products
A. CSF-Unitized Shunt, Contoured Regular, Low Pressure and Medium Pressure
Lot or serial number
- D13944
- D14216
- D33526
- D34610
- D37761
- D39539
- D39540
Model or catalog number
- 46022
- 46024
Companies
- Manufacturer
-
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES