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HEMODIALYSIS CATHETER SETS (2015-06-23)
- Starting date:
- June 23, 2015
- Posting date:
- August 11, 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-54624
Affected Products
- HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETERS
- HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
- PEDIATRIC HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS
- SILICON CATHETER SETS
Reason
Cracks in silicon extension tubing of hemodialysis catheters propagate over time resulting in holes because of inadequate use during the insertion procedure, that is, the extension line clamp is clamped onto the guide wire. The hole in the extension tubing leaks when the device is being pressurized with a syringe during flushing or during dialysis treatment.
Affected products
A. HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETERS
Lot or serial number
All
Model or catalog number
- SL15C
- SL20C
- SL24C
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES
B. HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
Lot or serial number
All
Model or catalog number
- SL15E
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES
C. PEDIATRIC HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS
Lot or serial number
All
Model or catalog number
- SL12P
- SL18P
- SL24P
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES
D. SILICON CATHETER SETS
Lot or serial number
All
Model or catalog number
- MC101241
- MC101242
- MC101243
- SDL136E
- SDL138E
- SDL139E
- SL28
- SL32
Companies
- Manufacturer
-
Medical Components Inc,
Also trading as Medcomp
1499 Delp Drive
Harleysville
19438
Pennsylvania
UNITED STATES