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

• 
  Reason
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  Affected products

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