Sharesource Connectivity Platform 5C9400 (UDI 55413765565699)Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K151525); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 30, 2021Terminated

   Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

   Z-2173-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151525. One submission often covers many models, so check the product and lot details in each record.

• Z-0550-2024 · Nov 15, 2023 · Open, Classified
  Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
• Z-2174-2021 · Jun 30, 2021 · Terminated
  Kaguya Automated Peritoneal Dialysis System
• Z-0849-2019 · Dec 11, 2018 · Terminated
  AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients und
• Z-0850-2019 · Dec 11, 2018 · Terminated
  Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients un
• Z-2597-2018 · Jul 12, 2018 · Terminated
  power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
• Z-3133-2017 · Sep 1, 2017 · Terminated
  Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
• Z-1565-2016 · Feb 16, 2016 · Terminated
  Automated peritoneal dialysis (APD) cycler