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Cardiovascular Procedure Kits (2013-06-07)
- Starting date:
- June 7, 2013
- Posting date:
- October 16, 2013
- 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-36177
Recalled Products
A. Cardiovascular Procedure Kit (X-Coated Perfusion Pack)
B. Cardiovascular Procedure Kit (Fx Recirculation Line)
Reason
The over-pressure safety valves that are the subject of this recall (LN130B) are not cleared by the FDA with an indication for use on the arterial side of the extracorporeal bypass circuit. These devices are cleared with an indication for use on the venous side of the extracorporeal circuit.
Affected products
A. Cardiovascular Procedure Kit (X-Coated Perfusion Pack)
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- 73673-02
- 73679-01
- 74006
- 74226
- 74237-01
- 74340
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
125 Blue Ball Road
Elkton
21921
Maryland
UNITED STATES
B. Cardiovascular Procedure Kit (Fx Recirculation Line)
Lot or serial number
- NP12
- PD05
- PE30
- PL17
- PN19
- QA07
- QA28
Model or catalog number
- 72987
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
125 Blue Ball Road
Elkton
21921
Maryland
UNITED STATES