Baxter Dialysis Machines (2020-11-17)
- Starting date:
- November 17, 2020
- Posting date:
- December 11, 2020
- 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-74511
Last updated: 2020-12-10
Affected Products
A. AK 95 S
B. AK 200 S
C. AK 200 ULTRA S
D. AK 96
E. AK 96
F. AK 98
G. AK 98
Reason
Baxter has not validated the use of any connectors placed between the blood set and the patient's blood access with Baxter dialysis machines. The use of connectors with potentially incompatible material may increase the risk for leakage in the extracorporeal circuit and may prevent a secure connection between the blood set and the patient's blood access device.
Affected products
A. AK 95 S
Lot or serial number
All lots.
Model or catalog number
AK-95S
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
B. AK 200 S
Lot or serial number
All lots.
Model or catalog number
107470
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
C. AK 200 ULTRA S
Lot or serial number
All lots.
Model or catalog number
107469
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
D. AK 96
Lot or serial number
All lots.
Model or catalog number
110661
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
E. AK 96
Lot or serial number
All lots.
Model or catalog number
110373
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
F. AK 98
Lot or serial number
All lots.
Model or catalog number
115249
115251
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN
G. AK 98
Lot or serial number
All lots.
Model or catalog number
955406
955407
Companies
- Manufacturer
-
Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN