Class II — Ferno-Washington Inc
| Recalling firm | Ferno-Washington, Inc. |
|---|---|
| Registered facility | FERNO-WASHINGTON, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Product | 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. |
| Quantity | 270 |
| 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 recall. There is one Canadian account for this recall. There are no Mexican accounts for this recall. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALI… |
| Initiated | 2016-03-10 |
| Classified | 2016-05-04 |
| Terminated | 2016-08-23 |
| Recall number | Z-1604-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ferno-Washington Inc (Z-1604-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73641/
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