GF Health Products, Inc.
Warwick, RI, US
GF Health Products, Inc. appears in FDA device records in Warwick, RI. FDA records list no 510(k) clearances, no PMA records and 5 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to GF Health Products, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- GF Health Products, Inc./d.b.a.Basic American Metal Productsenforcement report, recall
- Graham Field Atlantarecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2428983 | 2427360 | GF Health Products, Inc | 1 GRAHAM FIELD WAY, Atlanta, GA 30340 US | 2026 | and 5 more, listed in full below |
| 1218367 | 1218367 | GF Health Products, Inc. | 33 Plan Way Bldg 2, Warwick, RI 02886 US | 2026 | |
| 1932809 | 1000147952 | GF Health Products, Inc. | 12055 Missouri Bottom Rd, HAZELWOOD, MO 63042 US | 2026 | No device listings on this registration |
| 2183191 | 2183191 | GF Health Products, Inc. | 336 Trowbridge Dr, Fond du Lac, WI 54937 US | 2026 | |
| 3004915858 | 3004915858 | GF Health Products, Inc. | 6029 Bandini Blvd, Commerce, CA 90040 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILSAdaptor, Hygiene
- IKXAid, Transfer
- FNLBed, Ac-Powered Adjustable Hospital
- FNJBed, Manual
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use
- JXLBlock, Bite
- GBBChair, Surgical, Ac-Powered
- FZKChair, Surgical, Non-Electrical
- INMChair, With Casters
- FMWCover, Mattress (Medical Purposes)
- KICCushion, Flotation
- FNGLift, Patient, Ac-Powered
- IKYMattress, Flotation Therapy, Non-Powered
- PHSOral Airway Assist
- FMPProtector, Skin Pressure
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FZMStool, Operating-Room
- FPOStretcher, Wheeled
- KGXTape And Bandage, Adhesive
- ITJWalker, Mechanical
- IORWheelchair, Mechanical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1353-2021 | Drop Arm Versamode" | The front casters on the 6810A Lumex Drop Arm Versamode are incorrect. | Class II | Terminated | |
| Z-0732-2017 | Lumex, Patriot Full Electric Homecare Bed, & Patriot LX Full Electric Homecare Bed containing the Okin Dumat 3 Head/Foot Motors. Description Part Number Motor and Pendant Patriot Full Electric 120V 690-3001-943 / 690-7001-943 Boxed Full Electric 220V Motor 690-3220-943 Motor and Pendant Patriot LX Full Electric 120V 690-8004-912 | GF Health Products, Inc., in conjunction with OKIN America, has initiated a voluntary field correction affecting the OKIN America "DUOMAT 3" Head/Foot motor used in the manufacture of our Lumex Patriot Full Electric Bed Model US0458/US0468 and Patriot LX Full Electric Bed Model US6000. The failure mode is directly related to contaminated material in the plastic housing used to produce the DUOMAT 3 motor. Contaminated motor housings may crack resulting in a motor that will no longer actuate the head section per the intended design. If the head section were to fall it is unlikely but possible an injury could occur. No injuries have been reported. | Class II | Terminated | |
| Z-2656-2014 | Zenith Slide W-I-D-E Long Term Care Bed, Model(s) APS98674, APS9867406, APS986741, APS986742, ZG58674, ZG78674, ZZ78674, ZZ98674, and ZZ98774. Designed for use within an institutional healthcare environment (i.e. assisted living, skilled nursing, transitional care, rehabilitation centers, etc.). | The bed head deck may fail to elevate as expected during normal operation. When the non-operation occurs, the head deck remains in the lowered horizontal / flat position and will no longer function as intended. | Class II | Terminated | |
| Z-1536-2012 | LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels, Item 690-7604-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Walnut Panels, Item 690-7004-000 Manufactured for : GF Heath Products, Inc., Atlanta, Georgia 30360 Made in China. Therapeutic bed intended for home use. | GF Health Products, Inc., is conducting a recall on the Lumex Patriot Full Electric Homecare "Bed Ends" manufactured 3/27/09, 5/9/09, 5/30/09 and 6/20/09. The supplier deviated from the print specifications of a machined pin to a sheared pin. This deviation has the potential to provide room for the pin to move during use. If failure were to occur, the bed could descend rapidly causing non-typic | Terminated | ||
| Z-0139-2010 | John Bunn 1392 Series Jackson Tracheostomy Stainless Steel Tube. | Incorrect material. Manufacturer changed the material of the trach tube from Stainless Steel to German silver/nickel, contrary to product specifications. | Terminated | ||
| Z-0772-2007 | Lumex Walkabout Lite Four-Wheel Rollator, Manufactured for: Graham-Field Health Products, Atlanta, Georgia 30360. | The caster bolt stem/screw may loosen over time causing the wheel to come off. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain