The Recall Desk
ModerateFDA (Devices)·Z-1604-2016·Announced 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.

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 and involves a labeling error (swapped adult/pediatric packaging) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Ferno-Washington Inc. is recalling 270 units of traction splint strap kits, specifically the Strap Kit Adult Model 444. The recall was initiated after the firm determined that its supplier had incorrectly labeled the outside poly-bags. Specifically, packaging labeled "Adult" contained pediatric splint straps, and packaging labeled "Pediatric" contained adult splint straps.

The affected products are strap kits containing 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 recall covers units distributed worldwide, including specific US states and countries such as the UAE, Malaysia, the United Kingdom, Slovakia, South Africa, Qatar, and Australia.

This recall is classified as Class II by the FDA. The hazard involves the potential use of the wrong size of traction splint straps due to the labeling error. Consumers and healthcare providers should stop using the affected strap kits and contact the recalling firm for instructions on return or replacement.

The recalled product

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.
Affected units
270

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 Adult Model 444

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 →