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Terumo Cardiovascular Procedure Kits (2016-07-28)
- Starting date:
- July 28, 2016
- Posting date:
- August 10, 2016
- 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-59760
Affected products
- A. Cardiovascular procedure Kit ( x-coated heart lung)
- B. Cardiovascular procedure kit (CArdioplegia set)
- C. CArdiovasuclar procedure kit (x-coated perfusion pack)
Reason
This safety alert is to notify that a portion of tubing within Terumo Cardiovascular Procedure Kit is labeled as x-coating surface coated. However, due to processing issues all of the tubing in the kit may be non-coated.
Affected products
A. Cardiovascular procedure Kit ( x-coated heart lung)
Lot or serial number
- UG20
- UG20T
Model or catalog number
- 74999-01
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
28 Howe Street, P.O. Box 289
Ashland
01721
Massachusetts
UNITED STATES
B. Cardiovascular procedure kit (CArdioplegia set)
Lot or serial number
UG20
Model or catalog number
75956
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
28 Howe Street, P.O. Box 289
Ashland
01721
Massachusetts
UNITED STATES
C. CArdiovasuclar procedure kit (x-coated perfusion pack)
Lot or serial number
UG13
UG13T
UG20
Model or catalog number
75295-01
75296-01
Companies
- Manufacturer
-
Terumo Cardiovascular System Corporation
28 Howe Street, P.O. Box 289
Ashland
01721
Massachusetts
UNITED STATES