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CODMAN CERTAS THERAPY MANAGEMENT SYSTEM6 (2015-06-24)
- Starting date:
- June 24, 2015
- Posting date:
- July 8, 2015
- 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-54122
Recalled Product
A.CODMAN CERTAS THERAPY MANAGEMENT SYSTEM6
Reason
CODMAN Neuro is recalling and replacing the CODMAN CERTAS Therapy Management System (TMS), 1st generation, with the CODMAN CERTAS tool kit, 2nd generation, that contains improvements for the indication and adjustment of the valve setting. Some components of the 1st generation are not compatible with the components of the 2nd generation, and the incompatibility could result in reduced indicating/adjusting performance and lead to symptoms associated with over/under drainage of cerebrospinal fluid. This incompatibility is between tool kit components only.
Affected products
A.CODMAN CERTAS THERAPY MANAGEMENT SYSTEM6
Lot or serial number
AM1108A
AM1108AR
Model or catalog number
82-8850
Companies
- Manufacturer
-
Medos International SARL
Chemin-Blanc 38
Le Locle
2400
SWITZERLAND