Bottle, Collection, Vacuum
FDA product code KDQ · Class II (moderate risk) · 21 CFR 880.6740 · General Hospital
48510(k) clearances
0PMA approvals
33recalls
Manufacturers
- Atrium Medical Corporation 8
- Deknatel, Inc. 5
- Bd Becton Dickinson Vacutainer Systems Preanalytic 2
- Boehringer Laboratories 2
- Davol, Inc. 2
- Sherwood Medical Co. 2
- Abco Dealers, Inc. 2
- Conphar, Inc. 1
- Snyder Laboratories, Inc. 1
- Chesebrough-Pond'S U.S.A. Co. 1
- Millicore AB 1
- Harvard Laboratories 1
- Respiratory Care, Inc. 1
- Anchor Brush Co., Inc. 1
- Blair Medical Products 1
- K & G Healthcare Ind., Inc. 1
- Bentley Laboratories, Inc. 1
- C.R. Bard, Inc. 1
- Consolidated Medical Equipment, Inc. 1
- Ludwig Medical, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081718 | Express Chest DrainKDQ · Special | Atrium Medical Corp. | 07/25/2008SE |
| K062302 | Millicore AB Digivent Chest Drainage SystemKDQ · Traditional | Millicore AB | 10/06/2006SE |
| K043582 | Ocean Chest DrainKDQ · Special | Atrium Medical Corp. | 01/21/2005SE |
| K984496 | Atrium Medical Corporation Express Chest DrainKDQ · Traditional | Atrium Medical Corp. | 05/05/1999SE |
| K962856 | Pleur-Evac Sahara Adult/Pediatric Chest Drainage System Model S-1100, S-1200, 2-2100…KDQ · Traditional | Deknatel, Inc. | 08/28/1996SE |
| K961287 | Rocket Pleuraseal II Chest Drainage SystemKDQ · Traditional | Rocket Medical Plc | 07/26/1996SE |
| K962168 | Mucus Specimen TrapKDQ · Traditional | Sage Products, Inc. | 07/22/1996SE |
| K950677 | Atrium Dry Suction Control Water Seal Chest DrainKDQ · Traditional | Atrium Medical Corp. | 04/13/1995SE |
| K941818 | PM9000 Vac TrapKDQ · Traditional | Precision Medical, Inc. | 12/12/1994SE |
| K932327 | Thora-Klex 350 ML Pediatric Chest Drainage SystemKDQ · Traditional | Davol, Inc. | 07/13/1993SE |
| K912704 | Atrium 2000 Chest DrainKDQ · Traditional | Atrium Medical Corp. | 08/26/1991SE |
| K905768 | Pleur-Evac Chest Drainage SystemsKDQ · Traditional | Deknatel, Inc. | 02/11/1991SE |
| K897125 | Atrium 2000, Chest DrainKDQ · Traditional | Atrium Medical Corp. | 03/30/1990SE |
| K896697 | Pleur-Evac(R) A-6020--INFANT Single Use Chest DraiKDQ · Traditional | Deknatel, Inc. | 02/08/1990SE |
| K896127 | Thora-Klex Chest Drainage UnitKDQ · Traditional | Davol, Inc. | 01/24/1990SE |
| K892915 | Pleur-Evac A-8002--ADULT/PEDIATRIC Dual CollectionKDQ · Traditional | Deknatel, Inc. | 06/21/1989SE |
| K882468 | Eliminator Air FilterKDQ · Traditional | Apex Medical, Inc. | 08/29/1988SE |
| K882223 | PLEUR-EVAC-A-7000--ADULT/PEDI Chest Drainage SystKDQ · Traditional | Deknatel, Inc. | 08/16/1988SE |
| K881149 | Mucus Trap or Suction TrapKDQ · Traditional | Ferguson Medical | 06/14/1988SE |
| K863561 | Uresil Thoracic VentKDQ · Traditional | Uresil Corp. | 09/23/1986SE |
| K861025 | T-Vac Pleural Drainage Unit, 7800 SeriesKDQ · Traditional | Boehringer Laboratories | 04/28/1986SE |
| K855074 | Filtered Vacuum Safety Trap BottleKDQ · Traditional | Boehringer Laboratories | 03/13/1986SE |
| K854359 | LM2000A Surgical Suction MonitorKDQ · Traditional | Engineering, Inc. | 03/03/1986SE |
| K860023 | Compact 2000 Water Seal Chest Drainage UnitKDQ · Traditional | Atrium Medical Corp. | 01/10/1986SE |
| K854634 | Bard Parker Thoracic VentKDQ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 12/27/1985SE |
| K844853 | Nifa Non Invasive Flutter AssemblyKDQ · Traditional | Emergency Management Products, Inc. | 12/12/1985SE |
| K851244 | Greco-Harvey Surfactant Bonded Cath for AnesthesioKDQ · Traditional | Cook, Inc. | 11/19/1985SE |
| K851892 | Compact 2000KDQ · Traditional | Atrium Medical Corp. | 06/14/1985SE |
| K851316 | Abco Suction CanisterKDQ · Traditional | Abco Dealers, Inc. | 05/08/1985SE |
| K844942 | Plura-Gard Chest Drainage SystemKDQ · Traditional | Consolidated Medical Equipment, Inc. | 03/12/1985SE |
| K830671 | Thorax-Klex Chest Drainage UnitKDQ · Traditional | C.R. Bard, Inc. | 03/29/1983SE |
| K812746 | Thoracic Drainage Set #55-DB2-GKDQ · Traditional | J. H. Emerson Co. | 10/26/1981SE |
| K812224 | Pleural Drainage System #PDS-4300KDQ · Traditional | Bentley Laboratories, Inc. | 09/09/1981SE |
| K812139 | Vacuum Suction FilterKDQ · Traditional | K & G Healthcare Ind., Inc. | 08/20/1981SE |
| K811437 | Modified Thoracentesis CatheterKDQ · Traditional | Blair Medical Products | 08/13/1981SE |
| K811955 | Calibrated Breathing System CollectionKDQ · Traditional | Anchor Brush Co., Inc. | 08/04/1981SE |
| K811192 | Vac-Rite Sunction CollectionKDQ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/02/1981SE |
| K810574 | Suction Collection Bottle, DisposableKDQ · Traditional | Harvard Laboratories | 04/21/1981SE |
| K810892 | Electro-Suction UnitKDQ · Traditional | Jedmed Instrument Co. | 04/17/1981SE |
| K802174 | Argyle Suction Canister W/Disp. LinerKDQ · Traditional | Sherwood Medical Co. | 09/26/1980SE |
| K801221 | Thora-Drain III Plastic Drainage SystemKDQ · Traditional | Chesebrough-Pond'S U.S.A. Co. | 06/09/1980SE |
| K800861 | Snyder Hemovac Chest Drainage SolutionKDQ · Traditional | Snyder Laboratories, Inc. | 05/02/1980SE |
| K791254 | Conphar Silicone Drains-SterileKDQ · Traditional | Conphar, Inc. | 08/03/1979SE |
| K790379 | Sep-T-Vac Suction Cannister W/ TubingKDQ · Traditional | Sherwood Medical Co. | 04/10/1979SE |
| K781279 | Suction CanisterKDQ · Traditional | Abco Dealers, Inc. | 08/10/1978SE |
| K781234 | Tubes, Lukens, TomasKDQ · Traditional | Ludwig Medical, Inc. | 08/10/1978SE |
| K770649 | Vac-RiteKDQ · Traditional | Medical Development Co. | 06/02/1977SE |
| K761202 | Aqua-SealKDQ · Traditional | Respiratory Care, Inc. | 12/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3105-2024 Class II | Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF…Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of… | MEDLINE INDUSTRIES, LP - Northfield | 06/27/2024Open, Classified |
| Z-2709-2024 Class II | Medline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF…A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2699-2024 Class II | 1,5L MED-SOFT SINGLE LINER WITH SOLIDIFIER, REF OR1920PGA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2698-2024 Class II | 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2697-2024 Class II | 1,5L MED-SOFT LINER W/ 6MMX1,8M TUB. & ADULT VC, REF OR53926A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2696-2024 Class II | 1500ML SOFT LINER, 1/4X6 TBG NS, REF OR926KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2695-2024 Class II | LINER, SOFT, SUCTION CANISTER, 1500CC, REF OR929KA slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-2694-2024 Class II | LINER, SOFT, SUCTION CANISTER, 1500CC, REF DYNDSCL1500A slight dimensional variation which has the potential for increased difficulty fitting into outer canister. | MEDLINE INDUSTRIES, LP - Northfield | 03/22/2024Open, Classified |
| Z-0485-2024 Class II | Atrium Oasis Dry Suction Water Seal Chest Drain, Part Number: 3600-100, DRAIN, OASIS…Product was re-processed and re-sterilized by a third party using packaging configurations and a… | Atrium Medical Corporation | 09/05/2023Open, Classified |
| Z-1303-2023 Class II | Express Mini 500 Dry Seal Chest Drain, Part Number 16400The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest… | Atrium Medical Corporation | 03/01/2023Open, Classified |
| Z-1302-2023 Class II | Atrium Pneumostat Chest Drain Valve, Part Number 16100The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest… | Atrium Medical Corporation | 03/01/2023Open, Classified |
| Z-1283-2023 Class II | DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000BThe reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid… | DeRoyal Industries Inc | 02/09/2023Open, Classified |
| Z-0235-2023 Class II | Atrium Ocean Wet Suction Water Seal Chest Drain- Product Code: 2002-000Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no… | Atrium Medical Corporation | 10/18/2022Open, Classified |
| Z-1607-2022 Class II | GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher… | Mckesson Medical-Surgical Inc. Corporate… | 05/25/2022Open, Classified |
| Z-0307-2022 Class II | The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It…Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable… | Atrium Medical Corporation | 10/22/2021Open, Classified |
| Z-2592-2021 Class II | Atrium Pneumostat Chest Drain Valve, Part Number 16100The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device… | Atrium Medical Corporation | 08/26/2021Open, Classified |
| Z-2749-2020 Class II | Pleur-Evac Adult-Ped Wet, LF Eng/Spanish, product code: A-8000I-06 - Product Usage:…Potential for sterile packaging to be compromised | Teleflex Medical Inc | 06/30/2020Terminated |
| Z-2748-2020 Class II | Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST…Potential for sterile packaging to be compromised | Teleflex Medical Inc | 06/30/2020Terminated |
| Z-0174-2020 Class II | Semi-Rigid Suction Canister, 3000cc. Model Numbers OR530 and OR530H. For OR530, the…Potential for the Semi-Rigid canister lid to fragment during use. | Medline Industries Inc | 01/31/2019Open, Classified |
| Z-1210-2017 Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1209-2017 Class II | Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1206-2017 Class II | Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-1205-2017 Class II | Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended…Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal… | Atrium Medical Corporation | 12/23/2016Terminated |
| Z-0352-2017 Class II | Rigid Suction Canister 3000 CC and 2000 CC.Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use. | Medline Industries Inc | 08/10/2016Terminated |
| Z-2239-2016 Class II | ATEC CANISTER. Suction Canister with Lid 490 cc., RX Only; Suction canister used to…Cracks ATEC Canister Lids. | Hologic, Inc | 05/31/2016Terminated |
| Z-0478-2016 Class I | The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial…Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to… | Stryker Sustainability Solutions | 11/17/2015Terminated |
| Z-1404-2015 Class II | Pluer-evac Sahara Chest Drainage System, S-1100-08LF, Dry Suction/Dry Seal Control, Rx…Package contains incorrect sized unit: The adult sized S-1100-08LF product contains an infant sized chest… | Teleflex Medical | 03/13/2015Terminated |
| Z-0098-2015 Class II | DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE…These lots of suction canisters and lids have an insufficient seal under low or intermittent suction… | DeRoyal Industries Inc | 08/22/2014Terminated |
| Z-0097-2015 Class II | Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID…These lots of suction canisters and lids have an insufficient seal under low or intermittent suction… | DeRoyal Industries Inc | 08/22/2014Terminated |
| Z-1987-2013 Class II | PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated…Individual component's IFUs are not included with the kit. | Atrium Medical Corporation | 07/16/2013Terminated |
| Z-0101-2011 | NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only…Suction canisters may crack during use | DeRoyal Industries Inc | 07/01/2010Terminated |
| Z-0090-2010 | Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031…The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The… | Ohio Medical Corporation | 09/21/2009Terminated |
| Z-0089-2010 | Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031…The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The… | Ohio Medical Corporation | 09/21/2009Terminated |