Agency classClass IIOur severity:High FDA (Devices)·Z-3133-2017·Announced 2017-09-20

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Dialysis Equipment
Hazard: device-malfunction
inadequate-drain
slow-flow
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.

Same manufacturer · Baxter Healthcare Corp

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