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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 11 Results
510(K) Number: K102936
 
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L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized b... 2 10/03/2019 Baxter Healthcare Corporation
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice... 2 08/16/2017 Baxter Healthcare Corporation
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Aut... 2 08/16/2017 Baxter Healthcare Corporation
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patie... 2 01/19/2017 Baxter Healthcare Corporation
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled ... 2 08/22/2016 Baxter Healthcare Corp.
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis ... 3 11/17/2015 Baxter Healthcare Corp.
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Perso... 2 03/18/2015 Baxter Healthcare Corp.
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult rena... 2 03/04/2015 Baxter Healthcare Corp.
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage... 2 02/02/2015 Baxter Healthcare Corp.
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product code... 2 01/29/2015 Baxter Healthcare Corp.
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