Custom Tubing Packs (2021-03-19)
- Starting date:
- March 19, 2021
- Posting date:
- April 1, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-75283
Last updated:
2021-04-01
Affected Products
- HEART LUNG PERFUSION PACK WITH SOFTLINE
- CUSTOM PACK WITH SOFTLINE
- PERFUSION SET WITH SOFTLINE COATING
- PERFUSION TUBING PACK WITH BIOLINE COATING
- PERFUSION SET WITH BIOLINE COATING
Reason
The packs listed above contain component 700000172 which is a bacterial filter. DEKRA Certification GmbH (MCP's notified body) issued the decision letter regarding the design dossier review of Customized Tubing Sets (CTPs) under MDD recertification. Due to the insufficient evidence regarding the shelf life of this component, the overall shelflife of the finished tubing packs containing this component must be reduced by one year.
Affected products
A. HEART LUNG PERFUSION PACK WITH SOFTLINE
Lot or serial number
- 701062277
Model or catalog number
- BO-HQV 48707
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY
B. CUSTOM PACK WITH SOFTLINE
Lot or serial number
- 701063761
Model or catalog number
- BO-HQV 55004
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY
C. PERFUSION SET WITH SOFTLINE COATING
Lot or serial number
- 701070954
- 701070955
Model or catalog number
- BO-H 55815
- BO-H 55816
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY
D. PERFUSION TUBING PACK WITH BIOLINE COATING
Lot or serial number
- 701065229
- 701065246
- 701066180
Model or catalog number
- BEQ-H 48715
- BEQ-H 48730
- BEQ-H 84702
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY
E. PERFUSION SET WITH BIOLINE COATING
Lot or serial number
- 701062275
Model or catalog number
- BEQ-HQV 48707
Companies
- Manufacturer
-
MAQUET CARDIOPULMONARY GMBH
KEHLER STR. 31, RASTATT, GERMANY, 76437
RASTATT
76437
GERMANY