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.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
- Manufacturer
- Ferno-Washington Inc
- Hazard
- 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.
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