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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