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Recall Observatory FDA recall evidence

Device product

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.

Z-1603-2016

March 10, 2016

Class II

Product summary

Firm
Ferno-Washington Inc
Event
Event 73641
Status
Terminated
Classification
Class II
Quantity
153
Official record key
device-enforcement:Z-1603-2016

Official wording

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

Code information: Strap Kit Pediatric Model 443

Distribution pattern: 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..

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    incorrect labeling