Public recall detail

Ak98 Hemodialysis Machine

2024-10-31

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Recall Safety notice
Quick summary

Quick summary: Ak98 Hemodialysis Machine. Date: 2024-10-31.

Recommended action

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

Recall details

Quick summary: Ak98 Hemodialysis Machine. Date: 2024-10-31.

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
ProductAk98 Hemodialysis Machine
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76419

Affected products

ProductAk98 Hemodialysis Machine
LotMore than 10 numbers, contact manufacturer.
Model955406 955407 115251 955606 955605
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionAk98 Hemodialysis Machine

Issue

Baxter Healthcare Corporation (Baxter) is in the process of implementing an urgent medical device correction for the Ak98 hemodialysis machines listed. These devices are manufactured using peroxide-cured silicone tubing within the hydraulic circuit. The Baxter Ak98 dialysis machine is intended to be used for intermittent hemodialysis and/or isolated ultrafiltration treatments of patients with chronic or acute renal failure or fluid overload. Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to nondioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and ndl polychlorinated biphenyls (PCBs) when using certain peritoneal dialysis and hemodialysis devices. The source of the NDL PCBAs and/or NDL PCBs in those recalls was due to the manufacturing process of the silicone tubing. Recall Start Date: October 21, 2024

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceGeneral public Healthcare
CategoryHealth products - Medical devices - Gastroenterology and urology
CompaniesGambro Lundia Ab Magistratsvagen 16, Lund, Sweden, 22010
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76419
Background{}
CompaniesGambro Lundia Ab Magistratsvagen 16, Lund, Sweden, 22010
AudiencesGeneral public Healthcare
Source updated2024-10-31

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

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