FDA Recall Terminated

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.

Recall: Z-1603-2016 · Initiated March 10, 2016

Recall

Recall Number
Z-1603-2016
Event Number
73641
Firm
Ferno-Washington Inc
FEI Number
1523574
Product Code
NZD
Status
Terminated
Root Cause
Process control
Initiated
March 10, 2016
Terminated
August 23, 2016
Address
70 Weil Way, Wilmington, OH, 45177-9371

Description

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.

Reason

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

Action

Ferno-Washington, Inc , has contacted all customers via telephone on March 10, 2016. All products will be replaced with new products. For further questions, please call: (937) 283-2885.

Distribution

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. and to the countries of : UAE, MALAYSIA, UNITED KINGDOM, SLOVAKIA, SOUTH AFRICA, QATAR and AUSTRALIA..

Quantity

153