Ferno-Washington Inc
Wilmington, OH, US
FERNO-WASHINGTON, INC. appears in FDA device records in Wilmington, OH. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 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 5 510(k) clearances for Ferno-Washington Inc between 1986 and 1998. The busiest year on record is 1986, with 3. The most recent is 1998, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1993 | 1 |
| 1998 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | ILJ | Substantially Equivalent | |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | FPL | Substantially Equivalent | |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | HST | Substantially Equivalent | |
| K864269 | MODEL 35-B ALL LEVEL COT | FPO | Substantially Equivalent | |
| K862441 | EZ LOAD MODEL 30, ALL LEVEL COT | FPO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1523574 | 1523574 | FERNO-WASHINGTON, INC. | 70 WEIL WAY, Wilmington, OH 45177 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HSTApparatus, Traction, Non-Powered
- ILJBath, Hydro-Massage
- FPLIncubator, Neonatal Transport
- IQKOrthosis, Cervical
- FZFSplint, Extremity, Inflatable, External
- NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile
- FOXStand, Infusion
- FPPStretcher, Hand-Carried
- NZDStretcher, Patient Restraint
- FPOStretcher, Wheeled
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2760-2026 | Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Designed to load, unload, and secure a compatible wheeled stretcher inside a ground-based ambulance. Item no. 0567091 | Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of patient to healthcare facility. | Class II | Open, Classified | |
| Z-0133-2026 | FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES. | The fastening post hardware could loosen allowing the fastening post to detach from the cot | Class II | Open, Classified | |
| Z-0184-2023 | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/0822483 Note: Transcend Stair Chair Powertraxx (Item #0731403/UDI-DI 00190790004064) not included in this action). | Batteries could become unstable when not properly maintained and/or subjected to repeated drops, power washing directly into battery contacts or abuse, may result in a fire and/or injury | Class II | Open, Classified | |
| Z-1827-2017 | Ferno PROFlexx Model 28Z Chair Cot | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | Class II | Terminated | |
| Z-1604-2016 | Poly-bags containing the strap labeled with "Adult" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg. | On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled Pediatric conta | Class II | Terminated | |
| Z-1603-2016 | Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps, ankle wrap, a thigh pad and a heel stand. The strap kits are applied to the traction splint frame to immobilize and provide traction for a patients leg. | On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the outside poly- bag of the traction splint straps. The firm investigated and determined its supplier had labeled the outside packaging for the pediatric and adult traction splints straps incorrectly. The packaging labeled Adult contained a pediatric splint strap and the packaging labeled pediatric cont | Class II | Terminated | |
| Z-2826-2015 | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital patient transport. | Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability of the retention pin to stay seated which is necessary to preclude movement of the telescoping load frame. | Class II | Terminated | |
| Z-2461-2015 | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport. | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use. | Class II | Terminated | |
| Z-0995-2015 | Ferno Model 35X PROFlexx Stretchers, one unit per package | The wheel castor assemblies may be loosening on the stretchers. | Class II | Terminated | |
| Z-2465-2008 | Ferno Model 35X PROFlexX Ambulance Stretcher, Model #'s: 35X; 35XST; 35XIT. The Ferno Model 35-X PROFlexx ambulance stretcher is used to transport a patient during rescue or emergency situations as well as a means to transport patients for general medical purposes. | The Ferno Model 35-X PROFlexx legs could experience metal fatigue and possibly fracture after one to two years of use based on the usage and method of operation. | Terminated | ||
| Z-1859-2008 | Model 35A Series Mobile Transporters is an ambulance stretcher for patient transport. | A component defect was found in corner castings of the firm's wheeled ambulance stretchers. Some corner castings on the stretchers were found to be over-sized. Using an over-sized cone-shaped hole corner casting with an improperly seated shank pin could put undue stress on the top screw, possibly causing the screw securing a wheel to become loose or break and the wheel to detach from the stretcher | Terminated | ||
| Z-0202-06 | PROFlex Transporter, Model number 35P. The catalog number for the model 35P is PT3550. | The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher. | Terminated | ||
| Z-0201-06 | PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565. | The firm received complaints of the stretchers folding. A fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain