Health product recall

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

  1. AK 98, 115V BIO/ AK 98, 115V SELF-CARE
  2. 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