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Recall Observatory FDA recall evidence

Device product

AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

Z-1245-2015

April 03, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 70194
Status
Terminated
Classification
Class II
Quantity
55 systems
Official record key
device-enforcement:Z-1245-2015

Official wording

Reason: Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.

Code information: Product Code: 5C9310

Distribution pattern: US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.