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EDS 3 CSF External Drainage - With and Without Catheter (2014-09-16)
- Starting date:
- September 16, 2014
- Posting date:
- September 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-41527
Recalled products
- EDS 3 CSF External Drainage- Without Catheter
- EDS 3 CSF External Drainage - with Catheter
Reason
A recall of all lots of EDS 3 CSF External Drainage Systems, with an expiration on or before August 2017, is being conducted because the tubing within the system that drains CSF may leak or disconnect from the joints. Leakage and tube separations may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system or an increased risk of ventriculitis.
Affected products
A. EDS 3 CSF External Drainage - Without Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 82-1731
Companies
- Manufacturer
-
Codman and Shurtleff Inc.
325 Paramount Drive,
Raynham
02767-0350
Massachusetts
UNITED STATES
B. EDS 3 CSF External Drainage - with Catheter
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 82-1730
Companies
- Manufacturer
-
Codman and Shurtleff Inc.
325 Paramount Drive,
Raynham
02767-0350
Massachusetts
UNITED STATES