Ohio Medical LLC
Gurnee, IL, US
Ohio Medical LLC appears in FDA device records in Gurnee, IL. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Ohio Medical LLC between 2006 and 2008. The busiest year on record is 2006, with 1. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2008 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1419185 | 1419185 | Ohio Medical LLC | 1111 LAKESIDE DR, Gurnee, IL 60031 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KDQBottle, Collection, Vacuum
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated
- CAWGenerator, Oxygen, Portable
- KFZHumidifier, Non-Direct Patient Interface (Home-Use)
- BTAPump, Portable, Aspiration (Manual Or Powered)
- CANRegulator, Pressure, Gas Cylinder
- KDPRegulator, Vacuum
- BYXTubing, Pressure And Accessories
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1980-2025 | GCE HEALTHCARE Zen-O lite, Portable Oxygen Concentrator, Model RS-00608-X-S | Erroneous calibration values, potentially resulting in: as the device ages, oxygen purity will gradually decrease to the point where the device alarms to indicate low oxygen purity will be incorrect. | Class II | Open, Classified | |
| Z-0482-2022 | Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000. | Increase in premature device failures | Class II | Open, Classified | |
| Z-2995-2018 | Portable Suction Pump, (a) Style 758010, Model CARE-E-VAC 3, Ohio Medical LLC; (b) Style 758000, Model CARE-E-VAC 3, Ohio Medical LLC The care-e-(R)3 is a portable medical aspirator used to suction fluids or foreign bodies from a patient. The primary intended use is to aspirate saliva, mucous, vomitus or other aspirant from the mouth or airway to allow adequate respiration or ventilation of the patient. | The care-e-vac(R)3 Battery/AC Powered Portable Aspirator battery terminal may come in contact with the pump causing an electric short leading to damage to wiring and resulting in loss of function or an inoperable unit under battery power. | Class II | Terminated | |
| Z-2410-2018 | Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body. | Final quality control testing was not completed before the devices were distributed.. | Class II | Terminated | |
| Z-0833-2011 | Care E Vac 3 Portable Suction; Battery/AC Portable Aspirator; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 758000 The device is a portable aspirator to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient. | The D-14 diode on the circuit board may fail, resulting in a damaged, overheated circuit board. Also a screw used to attach one of the feet of the unit may damage the battery inside the device if the screw is over-tightened. | Terminated | ||
| Z-1778-2010 | NPWT Small Mobile Bag No Logo; an adjunct to the MoblVac Portable Wound Care Pump; Ohio Medical Corporation, 1111 Lakeside Drive, Gurnee, IL 60031; Model 769709. | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. | Terminated | ||
| Z-1777-2010 | MoblVac Portable Wound Care Pump; an AC/DC powered portable aspirator that provides negative pressure for the application of wound drainage; Ohio Medical Corporation, Gurnee, IL 60031; Models 769600 (with Truseal), 759600 (refurbished), 769600 Rental, 769601 (rental), 769602 (evaluation pump with Truseal) and 769610 (sales unit with case). | Ohio Medical has received a report of an explosive event with a MoblVac Portable Woundcare Pump housing where parts were separated while in an enclosed nylon transport bag during use. | Terminated | ||
| Z-0090-2010 | Vacuum Collection Bottle, 1 gallon (3200 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0302-600 (6700-209-500); the bottles are sold alone and with various cap & float assemblies: 0321-7986-800 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0018-800 - Bottle with V Wall Bracket, Cap & Float; 6700-0370-800 - Bottle with Floor Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids. | The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate. | Terminated | ||
| Z-0089-2010 | Vacuum Collection Bottle, 1/2 gallon (1300 mL); Ohio Medical Company, Gurnee, IL 60031; part number 0212-0301-600 (6700-0206-500); the bottles are sold alone and with various cap & float assemblies including: 0321-7986-801 - Bottle with Straight Wall Bracket, Cap & Float; 6700-0019-800 - Bottle with Floor Bracket, Cap & Float; 6700-0024-800 - Bottle with V Wall Bracket, Cap & Float. The collection bottles are part of a suction bottle assembly which is designed to collect various body fluids. | The re-useable collection bottles were made with polycarbonate instead of the specified polysulfone. The recommended cleaning of the bottles include use of ammonia and autoclaving, which may have an adverse impact on polycarbonate. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain