AK 98, 115V BIO/ AK 98, 115V SELF-CARE and AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE (2018-08-29)
- Starting date:
- August 29, 2018
- Posting date:
- September 7, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67702
Affected products
- AK 98, 115V BIO/ AK 98, 115V SELF-CARE
- AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE
Reason
Baxter is communicating important safety information regarding the potential for AK 98 hemodialysis devices to generate excessive Ultrafiltration (UF) in certain situations where treatment-related alarms occur, or where there is an ultrafilter leak. Excessive UF may present hazards for sensitive patients, such as low-weight patients, for whom target UF values of zero or very low volumes are desired.
Affected products
A. AK 98, 115V BIO/ AK 98, 115V SELF-CARE
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
B. AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE
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