Perfusion Pack, Custom Pack with SOFTLINE, Perfusion Set (with SOFTLINE, BIOLINE Coating) (2019-02-19)
- Starting date:
- February 19, 2019
- Posting date:
- March 15, 2019
- 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-69324
Affected Products
- Perfusion Pack
- Custom Pack with SOFTLINE
- Perfusion set with SOFTLINE Coating
- Perfusion Set with BIOLINE Coating
Reason
Maquet Cardiopulmonary has been informed that the printed information on the front and back side of the pre-bypass filter, showed incomplete print quality. Internal investigations have revealed that the print on the filters had already been partially removed out of the packaging or it was also detected that the printing could be removed by touching with hands. The print does not necessarily come off during transport. Even if the print is still fully intact it could be an affected device. The print may be removed when touched without any solvent used.
Affected products
A. Perfusion Pack
Lot or serial number
- 92266985
- 92267058
Model or catalog number
HQV 94500
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
B. Custom Pack with SOFTLINE
Lot or serial number
92246216
Model or catalog number
BO-HQV 55004
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
C. Perfusion set with SOFTLINE Coating
Lot or serial number
92247616
Model or catalog number
BO-HQV 46904
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY
D. Perfusion Set with BIOLINE Coating
Lot or serial number
92267194
Model or catalog number
BEQ-HQV 46904
Companies
- Manufacturer
-
Maquet Cardiopulmonary GmbH
Kehler Str. 31
Rastatt
76437
GERMANY