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Various Maquet Cardiopulmonary Devices (2017-07-28)
- Starting date:
- July 28, 2017
- Posting date:
- September 8, 2017
- 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-64438
Affected Products
- Heart Lung Perfusion Pack With Softline
- Custom Pack With Softline
- Plegiox Heat Exchanger With Softline
- Heat Exchanger Plegiox (With Bioline)
- Plegiox Heat Exchanger
- Cardioplegia Set With Bioline Coating
- Cardioplegia Set With Softline Coating
- Perfusion Set With Softline Coating
- Perfusion Tubing Pack With Bioline Coating
- Perfusion Set With Bioline Coating
Reason
Maquet Cardiopulmonary GmbH (MCP) internal investigations have revealed that the specification of the performance factor (PF) at flow rates of 1 liter per minute is not always maintained as defined in instruction for use (IFU). Deviations up to minus 20% were identified during in-house testing.
Affected products
A. Heart Lung Perfusion Pack With Softline
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 48707
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
B. Custom Pack With Softline
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 46901
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
C. Plegiox Heat Exchanger With Softline
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 47906
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
D. Heat Exchanger Plegiox (With Bioline)
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 52700-1
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
E. Plegiox Heat Exchanger
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 59203
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
F. Cardioplegia Set With Bioline Coating
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 59204
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
G. Cardioplegia Set With Softline Coating
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 59205
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
H. Perfusion Set With Softline Coating
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 66604
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
I. Perfusion Tubing Pack With Bioline Coating
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 66605
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
J. Perfusion Set With Bioline Coating
Lot or serial number
MFG 2015.07.31 - 2017.07.31
Model or catalog number
BO-HQV 66606
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY