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/ AK 98 V3 (2018-08-29)

Brand(s)
Last updated

Summary

Product
AK 98, 115V BIO/ AK 98, 115V SELF-CARE and AK98 V2 115V BIO VERSION / AK 98 V2 115V BIO SELF CARE/ AK 98 V3 (2018-08-29)
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Health professionals

Affected products

Affected products Lot or serial number Model or catalogue number
AK 98 All lots. 115249 115251
AK 98 (SW 2) All lots. 955406 955407
AK 98 (SW 3) All lots. 955606

Issue

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.

Recall start date: August 29, 2018

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies

 

Gambro Lundia AB
MAGISTRATSVAGEN 16, P.O. BOX 10101,
Lund
22010
SWEDEN

Published by
Health Canada
Audience
Health professionals
Recall class
Type I
Identification number
RA-58388

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