Food, drugs, devices › Ferno-Washington Inc
Device recall: Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg straps
Ferno-Washington Inc (Wilmington, OH) initiated this device recall on 10 Mar 2016; FDA lists 2 product records under event 73641, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 23 Aug 2016. Initiation: voluntary: firm initiated. Ferno-Washington Inc has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ferno-Washington Inc, Wilmington, OH.
Reason for recall
"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"
Distribution
"Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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. | 153 | Class II | Terminated | 11 May 2016 |
| 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. | 270 | Class II | Terminated | 11 May 2016 |
Context
Other enforcement events for Ferno-Washington Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Jun 2026 | Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for professional use only. Desi | Device | Class II | 1 |
| 11 Sep 2025 | FERNO POWER X2 POWERED AMBULANCE COT, Model/Catalog Number: 0015816; FOR USE IN GROUND TRANSPORTATION AMBULANCES. | Device | Class II | 1 |
| 7 Oct 2022 | FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model Number #0822484/082248 | Device | Class II | 1 |
| 8 Mar 2017 | Ferno PROFlexx¿ Model 28Z Chair Cot | Device | Class II | 1 |
| 3 Aug 2015 | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System Product Usage: Stretcher for pre-hospital pat | Device | Class II | 1 |
| 1 May 2015 | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport. | Device | Class II | 1 |
| 3 Dec 2014 | Ferno Model 35X PROFlexx Stretchers, one unit per package | Device | Class II | 1 |
All 8 events for Ferno-Washington Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US Distribution to the states of : AK ,AZ ,CA, CO, FL ,GA ,HI, IL ,IN ,KY ,MA ,MI ,MS ,NC ,NE ,NJ ,NY ,OH,ON,TX ,VA ,WI , and WV. There are no government accounts for this…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 23 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.