The Recall Desk

FDA (Devices) recall action 73641

Ferno-Washington Inc recalled 2 products on 2016-05-11

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-05-11
Critical
0
Units
423

Why these products were recalled

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

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-05-11

    Ferno-Washington Recalls Pediatric Traction Splint Straps Due to Labeling Error

    Ferno-Washington is recalling 153 pediatric traction splint strap kits because they were shipped in adult-labeled packaging. This labeling error could lead to the use of the wrong size equipment for patients.

    Product
    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.
    Category
    Distribution
    21 states
  • ModerateFDA (Devices)··2016-05-11

    Ferno-Washington Recalls Traction Splint Straps Due to Incorrect Packaging Labels

    Ferno-Washington Inc. is recalling 270 traction splint strap kits because the outside packaging labels for adult and pediatric sizes were swapped.

    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.
    Category
    Distribution
    21 states