Public recall detail

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)

2021-12-05

medium
Recall Safety notice
Quick summary

Quick summary: 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) . Date: 2021-12-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: 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) . Date: 2021-12-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandGambro Lundia AB
ProductAK 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)
IssueMedical devices - Performance
Recall classType I
IdentificationRA-58388

Affected products

ProductAK 98
LotAll lots.
Model115249 115251
Serial numberAll lots.
DescriptionAK 98
ProductAK 98 (SW 2)
LotAll lots.
Model955406 955407
Serial numberAll lots.
DescriptionAK 98 (SW 2)
ProductAK 98 (SW 3)
LotAll lots.
Model955606
Serial numberAll lots.
DescriptionAK 98 (SW 3)

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealth professionals
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesGambro Lundia AB MAGISTRATSVAGEN 16, P.O. BOX 10101, Lund 22010 SWEDEN
Published byHealth Canada
Recall classType I
Alert / recall typeHealth product recall
Identification numberRA-58388
Background{}
CompaniesGambro Lundia AB MAGISTRATSVAGEN 16, P.O. BOX 10101, Lund 22010 SWEDEN
AudiencesHealth professionals
Source updated2024-03-26

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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