Cannula, Injection
General, Plastic Surgery · 21 CFR 878.4200
Recent MDR events
74 adverse event reports on file
- VACUETTE PLASTIC CANNULA HOLDEX STERILENov 16, 2020MalfunctionGreiner Bio-one Gmbh8020040-2017-00032
- VACUETTE PLASTIC CANNULA HOLDEX STERILENov 2, 2020MalfunctionGreiner Bio-one Gmbh8020040-2018-00025
- VACUETTE PLASTIC CANNULA HOLDEX STERILENov 2, 2020MalfunctionGreiner Bio-one Gmbh8020040-2018-00024
- PLASTIC CANNULA HOLDEX HAEMONETICS STERIOct 30, 2020MalfunctionGreiner Bio-one Gmbh8020040-2018-00018
- PLASTIC CANNULA HOLDEX STERILEJul 29, 2020MalfunctionGreiner Bio-one Gmbh8020040-2020-00001
- ACCUPORTJan 14, 2020InjuryZimmer Knee Creations, Inc.3008812173-2020-00004
- ACCUPORTDec 19, 2019InjuryZimmer Knee Creations, Inc.3008812173-2019-00055
- INTERLINK INJECTION SITENov 22, 2019MalfunctionBecton Dickinson2243072-2019-02642
- ACCUPORTSep 24, 2019InjuryZimmer Knee Creations, Inc.3008812173-2019-00046
- ACCUPORTJul 30, 2019InjuryZimmer Knee Creations, Inc.3008812173-2019-00037
Event type breakdown
Recalls
7 recall events for this product code
- Hobbs Medical, Inc.Open, ClassifiedOct 7, 2022
Hobbs Scope Introducer
Device label display an incorrect expiration date, extends the shelf life of the product. Affected product distributed in the United States from 3/25/2018 to 9/28/2020, expiration dates between 2022-11-01 and 2025-09-01 (Devices have a lot number ending in R, or are kits containing at least 1 device with a lot number ending in R.)
Z-0019-2023 · View FDA record ↗ - Biologic Therapies, IncTerminatedApr 2, 2015
Bio-PLASTY Cannula (Needle)
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Z-1372-2015 · View FDA record ↗ - Biologic Therapies, IncTerminatedApr 2, 2015
Bio-MAC Cannula (Needle) Set
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Z-1373-2015 · View FDA record ↗ - Biologic Therapies, IncTerminatedApr 2, 2015
Bio-CORE Cannula (Needle) Set
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Z-1374-2015 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedJan 15, 2014
BD Interlink threaded lock cannula
BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the potential that a small percentage of the lot may exhibit open seals which adversely impacts unit package integrity and product sterility.
Z-0772-2014 · View FDA record ↗ - Maquet Cardiovascular Us Sales, LlcTerminatedJun 21, 2013
MAQUET GETINGE GROUP Arterial Cannula OD
The specified part numbers and lot numbers of Maquet Pediatric Arterial Cannula Packs may contain an incorrectly sized connector.
Z-1572-2013 · View FDA record ↗ - Wilson-Cook Medical IncTerminatedDec 7, 2005
Fusion OMNI- GT * DOME TIP: ERCP Catheter: 6.0 FR./200 CM. 8 Minimum Accessory Channel: 4.2 MM * Disposable Single Use Only * Compatible Wire Guide: .035'' * R
Misbranded; The catheter size listed on the product label is 6 French, which is inaccurate. The catheter size is more accurately described as 7 French.
Z-0270-06 · View FDA record ↗
Registered firms
83 firms currently registered for this product code
Greiner Mediscan Gmbh
KREMSMUNSTER Oberosterreich, AT
Cook Incorporated
Bloomington, IN, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Becton, Dickinson & Co.
BROKEN BOW, NE, US
Tf New Material Sci And Tec Co.,ltd
Huainan Anhui, CN
Jiangsu Caina Medical Co., Ltd
Jiangyin Jiangsu, CN
Nihon Chushashin Kogyo Co. Ltd.
Koga Ibaraki, JP
Bausch & Lomb Incorporated
Manchester, MO, US
Asanus Medizintechnik Gmbh
NEUHAUSEN OBECK Baden-Wurttemberg, DE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Bausch & Lomb Incorporated
Rochester, NY, US
Nutek Bravo, Hayward
Hayward, CA, US
Sterigenics Us Llc
Gurnee, IL, US
Mattes Instrumente Gmbh
Tuttlingen-Nendingen Baden-Wurttemberg, DE
Jakutec Medizintechnik Gmbh & Co. Kg
LIPTINGEN Baden-Wurttemberg, DE
Tekno Medical Optik-chirurgie Gmbh
TUTTLINGEN-Nendingen Baden-Wurttemberg, DE
Jarit Gmbh
Rietheim-Weilheim Baden-Wurttemberg, DE
Deroyal Industries, Inc.
POWELL, TN, US
Isomedix Operations Inc.
S Plainfield, NJ, US
Integra Lifesciences Production Corporation
Mansfield, MA, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Quality Tech Services, Llc
Bloomington, MN, US
Saferlife Products Co.,ltd.
Guangzhou Guangdong, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Conmed Corporation
WESTBOROUGH, MA, US
510(k) clearances
2 clearances for this product code