Bottle, Collection, Vacuum
General Hospital · 21 CFR 880.6740
Recent MDR events
2,145 adverse event reports on file
- OASISJul 28, 2026MalfunctionAtrium Medical Corporation3011175548-2026-000008
- OasisJul 28, 2026MalfunctionAtrium Medical Corporation3011175548-2026-000008
- OasisJul 28, 2026MalfunctionAtrium Medical Corporation3011175548-2026-000008
- MEDLINEJul 27, 2026MalfunctionMedline Industries, Lp1417592-2026-11108
- MEDLINEJul 22, 2026MalfunctionMedline Industries, Lp1417592-2026-07484
- OASISJul 16, 2026MalfunctionAtrium Medical Corporation3011175548-2026-000008
- ONE-VAC¿Jul 13, 2026MalfunctionMerit Medical Systems, Inc.25794635
- THORA-SEALJul 8, 2026InjuryCardinal Health 200, Llc1423537-2026-00223
- OASISJun 26, 2026MalfunctionAtrium Medical Corporation3011175548-2026-000007
- ETRAPJun 19, 2026MalfunctionUs Endoscopy1528319-2026-00071
Event type breakdown
Recalls
33 recall events for this product code
- MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedSep 11, 2024
Medline Semi-rigid suction liners labeled as follows:
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Z-3105-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2694-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2695-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926K
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2696-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2697-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2698-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PG
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2699-2024 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedAug 22, 2024
Medline medical procedure kits labeled as follows:
A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
Z-2709-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedDec 2, 2023
Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS SINGLE W/AC, 3600 SINGLE COLLECTION.
Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation.
Z-0485-2024 · View FDA record ↗ - Atrium Medical CorporationOpen, ClassifiedMar 30, 2023
Atrium Pneumostat Chest Drain Valve, Part Number 16100
The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide sufficient precaution or warning against the use of the device outside the healthcare setting.
Z-1302-2023 · View FDA record ↗
Registered firms
303 firms currently registered for this product code
Isomedix Operations, Inc.
Temecula, CA, US
Plasti-med Plastik Medikal Urunler San. Ve Tic. Ltd. Sti.
Tuzla Istanbul, TR
Cbr Enterprise Limited
Hong Kong, HK
Ningbo Great Mountain Medical Instruments Co.,ltd
Ningbo Zhejiang, CN
Sustain Medical
Fishers, IN, US
Br Surgical Llc
Jacksonville, FL, US
Jiangsu Jumao X-care Medical Equipment Co., Ltd
Danyang Jiangsu, CN
Cardinal Health Ireland Manufacturing Limited
TULLAMORE Offaly, IE
Drive Devilbiss Healthcare
Perris, CA, US
Shenzhen Balinda Technology Co.,ltd
Shenzhen Guangdong, CN
Shenzhen Linglu Hongtu Technology Co., Ltd
Shenzhen Guangdong, CN
Atrium Medical Corporation
Merrimack, NH, US
Kien An Transpower Company Limited
HO CHI MINH CITY Tay Ninh, VN
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
Hong Kong Lute Technology Co., Limited
HONG KONG, HK
Fridababy Llc
Miami, FL, US
Gcmedica Enterprise Ltd.(wuxi)
WUXI Jiangsu, CN
Shenzhen Lunata Technology Co. , Ltd
Shenzhen Guangdong, CN
Baby Health Care, Inc.
Newport Beach, CA, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Carefusion 2200, Inc.
Vernon Hills, IL, US
Entana Llc
Savannah, GA, US
Bard Peripheral Vascular, Inc.
TEMPE, AZ, US
Jiangsu Power Electromechanical Technology Co.,ltd
Danyang Jiangsu, CN
510(k) clearances
48 clearances for this product code
- Atrium Medical Corp.Jul 25, 2008
K081718 · EXPRESS CHEST DRAIN
- Millicore ABOct 6, 2006
K062302 · MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
- Atrium Medical Corp.Jan 21, 2005
K043582 · OCEAN CHEST DRAIN
- Atrium Medical Corp.May 5, 1999
K984496 · ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN
- Deknatel, Inc.Aug 28, 1996
K962856 · PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTR
- Rocket Medical PlcJul 26, 1996
K961287 · ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM
- Sage Products, Inc.Jul 22, 1996
K962168 · MUCUS SPECIMEN TRAP
- Atrium Medical Corp.Apr 13, 1995
K950677 · ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN