Recall Z-1604-2016— Ferno-Washington Inc
Class II · Terminated
Class II FDA medical device recall by Ferno-Washington Inc, initiated 2016-03-10, terminated 2016-08-23. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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 conta.
- Recalling firm
- Ferno-Washington Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-03-10
- Terminated
- 2016-08-23
- Firm location
- Wilmington, OH, United States
Product description
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.
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
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