Poly-bags containing splint strap labeled with Pediatric sticker recalled over labeling errors

Recall date

March 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Ferno-Washington Inc recalls Poly-bags containing splint strap labeled with "Pediatric" sticker. Each strap kit contains adjustable length leg strap…

Recall number

Z-1603-2016

FDA classification

Class II

Brand / firm

Ferno-Washington Inc

Sold / distributed

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.…

Why it was 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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.