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.
- Company
- Ferno-Washington Inc
- Recall Initiated
- March 10, 2016
- Terminated
- August 23, 2016
- Recall Number
- Z-1604-2016
- Quantity
- 270
- Firm Location
- Wilmington, OH
Reason for Recall
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 conta
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..
Lot / Code Info
Strap Kit Adult Model 444
Root Cause
Process control
Action Taken
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.