Catheter, Irrigation
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
5,798 adverse event reports on file
- Navarre Opti DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05391
- Navarre Universal DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05394
- Navarre Universal DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05395
- Navarre Universal DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05396
- Navarre Opti DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05393
- Navarre Opti DrainJul 31, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05397
- Navarre Universal DrainJul 30, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05356
- Navarre Universal DrainJul 30, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05357
- Navarre Universal DrainJul 30, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05355
- Navarre Opti DrainJul 30, 2026MalfunctionC.r. Bard, Inc. (basd) -30062607403006260740-2026-05364
Event type breakdown
Recalls
82 recall events for this product code
- Cook IncorporatedOpen, ClassifiedApr 6, 2026
COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1790-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0950-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0951-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0952-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0953-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0954-2026 · View FDA record ↗ - Rocket Medical PlcOpen, ClassifiedDec 18, 2025
Brand Name: Rocket
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
Z-0955-2026 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 1, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Z-1735-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 1, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Z-1736-2024 · View FDA record ↗ - Cardinal Health 200, LLCOpen, ClassifiedMay 1, 2024
Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.
Z-1737-2024 · View FDA record ↗
Registered firms
276 firms currently registered for this product code
Hollister Incorporated
LIBERTYVILLE, IL, US
Bausch & Lomb Incorporated
Manchester, MO, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Nouvag Ag
GOLDACH Sankt Gallen, CH
Isomedix Operations, Inc.
Libertyville, IL, US
Atria Co.
Seoul, KR
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Boston Scientific Corporation
Saint Paul, MN, US
Sterilization Services Of Virginia
RICHMOND, VA, US
Amis (xiamen) Cultural Creativity Co., Ltd
Xiamen Fujian, CN
Directmed, Inc.
GLEN COVE, NY, US
Isomedix Operations Inc.
WHIPPANY, NJ, US
Isomedix Operations, Inc.
Temecula, CA, US
Bioseal
PLACENTIA, CA, US
Jiangsu Zhiyu Medical Instrument Co., Ltd
West Taixing City Jiangsu, CN
Jiangsu New Pentastar Medical Products Co. Ltd.
Changzhou Jiangsu, CN
Interlinked Ab
Stockholm, SE
Cook Incorporated
Spencer, IN, US
B. Braun Medical Inc.
Allentown, PA, US
Arrow International Cr, A.s.
Hradec Kralove, CZ
Haemotronic De Mexico S De Rl
REYNOSA Tamaulipas, MX
Voom Medical Devices, Llc
Brentwood, TN, US
Merit Medical Nederland Bv
Maastricht Airport Limburg, NL
Angiodynamics, Inc.
Marlborough, MA, US
Changshu Beyond Medical Device Co., Ltd.
Changshu Jiangsu, CN
510(k) clearances
77 clearances for this product code
- Moerae Matrix, Inc.Mar 3, 2014
K131659 · MOERAE VEIN PREPARATION KIT
- Maquet Cardiovascular, LLCDec 17, 2008
K082725 · GRAFTGUARD PRESSURE CONTROLLING SYRINGE
- The Catheter Exchange, Inc.Oct 21, 2005
K052286 · DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
- Vescare, Inc.Mar 31, 2005
K043515 · GRAFTSAVER
- Misonix, Inc.Jan 10, 2002
K013417 · MISONIX IRRIGATION SYSTEM MOEDL BC20P
- Dmc Medical, Ltd.May 19, 2000
K000704 · DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
- Lysonix, Inc.Feb 3, 1998
K974233 · LYSONIX IRRIGATION SYSTEM
- Allegiance Healthcare Corp.Dec 4, 1997
K973703 · JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN