The Recall Desk
ModerateFDA (Devices)·Z-1603-2016·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error that could lead to the use of the wrong size medical device, which is a moderate risk but does not involve immediate life-threatening injury or death.

Plain-English summary

Ferno-Washington Inc is recalling 153 units of Poly-bags containing splint straps labeled with a "Pediatric" sticker. The recall was initiated after the firm determined that its supplier had incorrectly labeled the outside packaging for pediatric and adult traction splint straps. Specifically, packaging labeled "Adult" contained pediatric splint straps, and packaging labeled "Pediatric" contained adult splint straps.

The affected product is the Strap Kit Pediatric Model 443. Each kit contains adjustable length leg straps, an ankle wrap, a thigh pad, and a heel stand, which are applied to a traction splint frame to immobilize and provide traction for a patient's leg. The incorrect labeling poses a risk that medical providers might use the wrong size of splint strap for a patient, potentially compromising the effectiveness of the immobilization or traction.

The products were distributed worldwide, including to various US states and countries such as the UAE, Malaysia, and the United Kingdom. There are no government accounts for this recall, but one Canadian account is affected. Users should check their inventory for these specific kits and contact Ferno-Washington for instructions on how to return the product or obtain a replacement.

The recalled product

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.
Affected units
153

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Strap Kit Pediatric Model 443

Distribution

Part of a larger recall action

This product is one of 2 recalled by Ferno-Washington Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →