Health product recall

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