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Amia automated pd set with cassette

Official notice

4 Dec 2023

Last checked

4 Dec 2023

Medium riskHealth Canada

An official Health Canada notice concerns Amia automated pd set with cassette. Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices. The affected lots were distributed from 08/01/2023 to 09/26/2023 in Canada. Recall Start Date: November 16, 2023 Published 2023-12-04.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74669

Official notice

2023-12-04

The hazard

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices. The affected lots were distributed from 08/01/2023 to 09/26/2023 in Canada. Recall Start Date: November 16, 2023

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

74669

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Affected products

Product 1

Affected products - Amia Automated PD Set With Cassette, Lot or serial number - H23G14074 H23G15048 H23F27037 H23G07052 H23F24018 H23G16038 H23F29066 H23G11054 H23G17051 H23F28035, Model or catalog number - 5C5479

Risk / hazard

Baxter Corporation is issuing an urgent medical device recall for the Amia Automated Peritoneal Dialysis (APD) cycler set listed due to an increase in complaints related to failure alarms for wet cassette integrity test occurring on the Amia devices. The affected lots were distributed from 08/01/2023 to 09/26/2023 in Canada. Recall Start Date: November 16, 2023

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Baxter Healthcare, Amia Automated Pd Set With Cassette.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

74669

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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