Recall Z-1245-2015— Baxter Healthcare Corp.

Name: FDA recall Z-1245-2015
Creator: U.S. Food and Drug Administration
Published: 2014-04-03

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2014-04-03, terminated 2017-07-21. It names one FDA 510(k) clearance: K102936. Product: AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.. 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..

Recalling firm: Baxter Healthcare Corp.
Classification: Class II
Status: Terminated
Initiated: 2014-04-03
Terminated: 2017-07-21
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K102936 — HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RBaxter Healthcare Corp·cleared 2011-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.