Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device where functional defects (slow flow, inadequate drain) pose a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Baxter Healthcare Corp is recalling 164,700 units of the Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479. The affected units were distributed nationwide in the United States and in Canada.
The recall was initiated after the firm received increased customer complaints regarding specific alerts on certain lots of the product. These complaints included reports of Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts. The specific lot numbers affected are listed in the structured product information.
Consumers and healthcare providers should stop using the affected units and contact Baxter Healthcare Corp for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
- Manufacturer
- Baxter Healthcare Corp
- Affected units
- 164,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot numbers: H16G28107
- H16H01086
- H16H04114
- H16H09063
- H16H13032
- H16H19112
- H16H26034
- H16H30010
- H16I02017
- H16I06018
- H16I08071
- H16I12016
- H16I14103
- H16I16066
- H16I19060
- H16I21058
- H16I23047
- H16I26065
- H16I30091
- H16J03014
Distribution
Distributed nationwide across the United States.
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