110 results
·
78ms
·
Sources: EU EUDAMED, US FDA
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
CT190 DIALYZER
FDA Adverse Event
BAXTER HEALTHCARE RENAL DIV.·Product code FJI·September 21, 1998
BAXTER
FDA Adverse Event
Injury
·BAXTER HEALTHCARE RENAL DIV.·Product code FJI·March 15, 2000
BAXTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE RENAL DIV.·Product code FJI·March 15, 2000
BAXTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE RENAL DIV.·Product code FJI·March 15, 2000
BAXTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE RENAL DIV.·Product code FJI·March 15, 2000
BAXTER
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE RENAL DIV.·Product code FJI·March 15, 2000
BAXTER
FDA Adverse Event
Injury
·BAXTER HEALTHCARE (RENAL DIV)·Product code FKX·July 19, 2017
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
FDA Enforcement
Class II
·Terminated·Baxter Healthcare Renal Div·August 8, 2012
ARTERIAL BLOOD LINE
FDA Adverse Event
Malfunction
·RENAL DIV. BAXTER HEALTHCARE CORP.·Product code FJK·August 29, 1996
PERITONEAL DIALYSIS ULTRA BAG
FDA Adverse Event
Malfunction
·RENAL DIV. BAXTER HEALTHCARE COR.·Product code KDJ·August 26, 1996