Catheter, Infusion
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
35 adverse event reports on file
- CATHETER, INFUSIONDec 5, 2018InjuryMedtronic Neuromodulation3007566237-2018-03510
- ASCENDAMay 31, 2018InjuryMedtronic Neuromodulation3007566237-2018-01643
- 10F X 24CM SPLIT CATHNov 13, 2014MalfunctionMedcomp2518902-2014-00069
- 4F X 55CM SINGLE PRO-PICC CTOct 16, 2014MalfunctionMedcomp2518902-2014-00067
- 5F DUAL VASCU - PICCOct 2, 2014InjuryMedcomp2518902-2014-00063
- 5F DUAL VASCU-PICCOct 2, 2014InjuryMedcomp2518902-2014-00064
- 5F DUAL VASCU-PICCOct 2, 2014InjuryMedcomp2518902-2014-00065
- 7F X 60CM DUAL PRO LINE CTJun 25, 2014MalfunctionMedcomp2518902-2014-00041
- CATHETERMar 1, 2012MalfunctionMedtronic AveMW5024519
- CATHETERDec 27, 2011InjuryMedtronic Neuromodulation3007566237-2011-09352
Event type breakdown
Recalls
3 recall events for this product code
- Linvatec Corp. dba ConMed LinvatecTerminatedMar 25, 2011
***REF 24k100***QTY 1***24k Arthroscopy Outflow/Suction Tubing Set***MADE IN USA***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11311 CONCEPT BLVD, LARGO, GL 3377
On 09/13/2010 ConMed Linvatec, Largo, FL initiated a recall on 24k100 Arthroscopy Outflow/Suction Tube Set used with the ConMed Linvatec 24k Pump. The 24k100 Arthroscopy Outflow/Suction Tubing Set Lots 22747-000, 22748-000, and 2749-000 may have been incorrectly assembled and could potentially allow waste to enter the sterile field.
Z-1821-2011 · View FDA record ↗ - Medical Device Technologies, Inc.TerminatedJul 13, 2010
Angiotech Drainage Cather.
Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit, Stabilization Needles and Needle Guides for packaging integrity.
Z-2023-2010 · View FDA record ↗ - DePuy Mitek, Inc., a Johnson & Johnson Co.TerminatedUnknown
1113 Gravity Tube Set Pk/24 -SH
Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
Z-0695-2018 · View FDA record ↗
Registered firms
37 firms currently registered for this product code
Exel Inc.
Southaven, MS, US
B. Braun Dominican Republic Inc.
SANTO DOMINGO Distrito Nacional, DO
Mb Regentox Vietnam Trading Service Company Limited
Ho Chi Minh City, VN
B. Braun Medical Inc.
BETHLEHEM, PA, US
Falcon Surgical Co. (pvt.) Ltd.
Sialkot Punjab, PK
Sterigenics U.s., Llc
Atlanta, GA, US
Xinhua Surgical Instrument Co. Ltd.
ZIBO Shandong, CN
Maquiladora De Coahuila S De Rl De Cv
CUIDAD ACUNA Coahuila, MX
Isomedix Operations, Inc.
Temecula, CA, US
Steris Corporation De Republica Dominicana, S.r.l.
Santo Domingo, DO
Medical Components Inc
HARLEYSVILLE, PA, US
Surjex
SIALKOT Punjab, PK
Peak Medical Ltd.
Netanya Central, IL
Ningbo Risenmed Technology Co.,ltd.
Ningbo Zhejiang, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Sterigenics U.s., Llc
Queensbury, NY, US
Atlas Medical Products Llc
Hialeah, FL, US
O&m Halyard, Inc.
Alpharetta, GA, US
Pro-med (wuxi)imp.& Exp.co.,ltd.
Wuxi Jiangsu, CN
Depuy Mitek, Inc.
RAYNHAM, MA, US
Ustomed Instrumente Gmbh & Co. Kg
Tuttlingen Baden-Wurttemberg, DE
Greens Surgicals Private Limited
Vadodara Gujarat, IN
Martech Medical Products S. De Rl. De Cv.
MEXICALI Baja California, MX
Hospital & Homecare Imp. & Exp. Co., Ltd
NANJING Jiangsu, CN
510(k) clearances
14 clearances for this product code
- Vas-Cath of Canada , Ltd.Oct 24, 1986
K863982 · VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY
- Superior Plastic Products Corp.Apr 25, 1984
K840324 · SILICONE SUMP DRAIN 20 & 40 FRENCH
- Medical Components, Inc.Feb 14, 1984
K834615 · TRIPLE LUMEN INFUSIONCATHETERS-
- Argon Medical Corp.Jul 28, 1983
K831453 · SILCATH CENTRAL CATHETER TRAY W/18 GA
- Argon Medical Corp.Jun 8, 1983
K831451 · SILCATH CENTRAL CATHETER TRAY SIZE-
- American Heyer SchulteApr 12, 1983
K822096 · CHEMOTHERAPY INFUSION CATHETER
- Quest Medical, Inc.Jan 18, 1982
K813606 · SILICONE ELASTOMER INFUSION CATHETER
- Jelco LaboratoriesSep 12, 1979
K791372 · JELCO & KVO CATHETER PLACEMENT UNIT