Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration
Gastroenterology, Urology · 21 CFR 876.5980
Recent MDR events
66 adverse event reports on file
- AVANOS ASPIRATION CATHETEROct 4, 2022MalfunctionAvanos Medical, Inc.MW5112418
- 8FR REPLOGLE SUCT CATHApr 15, 2022MalfunctionCardinal Health9612030-2022-03221
- 8FR REPLOGLE SUCT CATHMar 29, 2022MalfunctionCardinal Health9612030-2022-03196
- LUKI ASP TUBES 61/4Aug 20, 2019MalfunctionCovidien1282497-2019-08612
- LUKI ASP TUBES 61/4Aug 20, 2019MalfunctionCovidiein1282497-2019-08613
- INJECTION NEEDLE CATHETERJun 5, 2019MalfunctionAvanos Medical Inc.8030647-2019-00052
- ETHOXDec 13, 2017MalfunctionEthox Llc.1314417-2017-00004
- ARGYLEJul 24, 2017MalfunctionCovidien1282497-2017-05237
- ARGYLEJul 24, 2017MalfunctionCovidien1282497-2017-05238
- ARGYLEJul 24, 2017MalfunctionCovidien1282497-2017-05239
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1451-2024 · View FDA record ↗ - MEDDEV USA, INC.TerminatedMay 17, 2012
50 Portal Vein Cannula REF 61.110.10.030 Size: Fr 10 Length: 12 Inches LL Connector LOT 120493 NON STERILE MEDDEV USA, INC. 100 Highland Park Village/Suite 200
The device was marketed without a 510(k) and is not sterile.
Z-1625-2012 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Cardinal Health 200, Llc
Waukegan, IL, US
Sterigenics U.s., Llc
Corona, CA, US
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Isomedix Operations Inc
El Paso, TX, US
Avanos Medical, Inc.
Alpharetta, GA, US
Quiroproductos De Cuauhtemoc S. De R.l. De C.v.
Cuauhtemoc Chihuahua, MX
Cardinal Health
Hazelwood, MO, US
Sterigenics U.s., Llc
Ontario, CA, US
Sterigenics Us Llc
Los Angeles, CA, US
Axiom Medical, Inc.
TORRANCE, CA, US
Isomedix Operations Inc
EL PASO, TX, US
Armm, Inc.
HUNTINGTON BEACH, CA, US
510(k) clearances
23 clearances for this product code
- Giltech Plus, Inc.Mar 18, 1999
K983624 · GILTECH PLUS CONNECTING TUBE SET
- Armm, Inc.Jun 19, 1998
K981286 · SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
- B.Braun Medical, Inc.Oct 27, 1997
K971259 · COMBIPORT FLUID LAVAGE DEVICE
- Ethox Corp.Feb 21, 1997
K962850 · TUM-E-VAC
- Ballard Medical ProductsJul 5, 1995
K951533 · EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT
- Orion Life Systems, Inc.Mar 21, 1994
K923497 · FLUSHING IRRIGATION SET
- Tri-Med Specialties, Inc.Sep 4, 1992
K920619 · TRI-MED GASTRIC LAVAGE SYSTEM
- Tri-Med Specialties, Inc.Sep 4, 1992
K920527 · TRI-MED QUICK-STEP GASTRIC LAVAGE KIT