Custom Tubing Packs (2021-01-21)
- Starting date:
- January 21, 2021
- Posting date:
- February 5, 2021
- 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-74915
Last updated:
2021-02-05
Affected Products
A. HEART LUNG PERFUSION PACK WITH SOFTLINE
B. CUSTOM PACK WITH SOFTLINE
C. CARDIOPLEGIA SET WITH BIOLINE COATING
D. CARDIOPLEGIA SET WITH SOFTLINE COATING
E. PERFUSION TUBING PACK WITH BIOLINE COATING
F. PERFUSION SET WITH BIOLINE COATING
Reason
Maquet Cardiopulmonary GmbH became aware of a missing cable tie in the cardioplegia (Plegiox) line to secure the connection between connector and tubing next to the roller pump for the article numbers subject of this FSN. A missing cable tie could lead to a leakage and/or loosening of the tube in the cardioplegia (Plegiox) line.
Affected products
A. HEART LUNG PERFUSION PACK WITH SOFTLINE
Lot or serial number
More than 10 numbers, contact manufacturer.
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
More than 10 numbers, contact manufacturer.
Model or catalog number
BO-HQV 66604
BO-HQV 66606
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
C. CARDIOPLEGIA SET WITH BIOLINE COATING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BEQ-H 48761
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
D. CARDIOPLEGIA SET WITH SOFTLINE COATING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BO-H 95260
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
E. PERFUSION TUBING PACK WITH BIOLINE COATING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BEQ-H 48730
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
F. PERFUSION SET WITH BIOLINE COATING
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BEQ-HQV 48707
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY