Baxter Amia Peritoneal Dialysis Cycler Set: Cassette Integrity Test Alarm Failures
Baxter is recalling 339,936 Amia peritoneal dialysis devices due to increased complaints of failure alarms for the Wet Cassette Integrity Test. This may prevent proper alerting during treatment.
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: This is a Class II recall involving a medical device for peritoneal dialysis, a life-sustaining critical treatment. The defect involves failure of a safety alerting system, which qualifies as a risk-of-harm product where injury has not yet been reported in the source text.
Plain-English summary
Baxter Healthcare Corporation is recalling 339,936 Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Sets (REF 5C5479). The recall affects devices distributed worldwide, including throughout the United States and Canada.
The recall is related to an increase in complaints regarding failure alarms for the Wet Cassette Integrity Test on affected devices.
Patients currently using affected devices should contact their healthcare provider or Baxter for guidance. Healthcare facilities should review the official FDA recall notice for detailed instructions and specific lot numbers affected by this recall.
The recalled product
- Product
- Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 339,936
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)
- UDI/DI 0085412153186
- Lot Numbers: H23F23028
- H23G11054
- H23F24018
- H23G12029
- H23F24034
- H23G13100
- H23F24067
- H23G14074
- H23F25049
- H23G15048
- H23F25056
- H23G16038
- H23F26047
- H23G17051
- H23F26054
- H23G18067
- H23F27037
- H23G19115
- H23F27045
Distribution
Distributed nationwide across the United States.
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