FKYClass IILife-sustaining

Connector, Tubing, Dialysate

Gastroenterology, Urology · 21 CFR 876.5820

MDR events10All time

Recalls0All time

Registered firms0Currently listed

510(k) clearances4All time

Recent MDR events

10 adverse event reports on file

DISPOSABLE BLOOD TUBE SETAug 14, 2023
InjuryQuanta Dialysis Technologies Ltd3013536188-2023-00006
DISPOSABLE BLOOD TUBE SETJul 20, 2023
InjuryQuanta Dialysis Technologies Ltd3013536188-2023-00005
DISPOSABLE BLOOD TUBE SETJul 14, 2023
InjuryQuanta Dialysis Technologies Ltd3013536188-2023-00004
DISPOSABLE BLOOD TUBE SET (HLS)May 12, 2023
InjuryQuanta Dialysis Technologies Ltd3013536188-2023-00003
INTEGRATED APO SET W/CASSETTE3-PRONGDec 3, 2008
MalfunctionBaxter Healthcare - Mountain Home1423500-2008-00963
AUTOMATED PD SET W/CASSETTE4 PRONGNov 10, 2008
MalfunctionBaxter Healthcare - Mountain Home1423500-2008-00900
HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONGSep 8, 2006
InjuryBaxter Healthcare1423500-2006-01003
MINNTECHJun 6, 1994
OtherMinntech Corp2243621-1994-00115
8" CATHETER EXTENSIONMar 21, 1994
MalfunctionFreseniuss Usa, Inc2243621-1994-08004
CENTURY SYSTEM BLOOD TUBINGJan 10, 1994
InjuryCobe Gambro Hospal2243621-1993-00249

Event type breakdown

Injury6

Malfunction3

Other1

Most-reported manufacturers

Quanta Dialysis Technologies Ltd4 Baxter Healthcare - Mountain Home2 Baxter Healthcare1 Cobe Gambro Hospal1 Freseniuss Usa, Inc1 Minntech Corp1

Recalls

0 recall events for this product code

No recalls on file for this product code.

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

4 clearances for this product code