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Bock,Otto,Orthopedic Ind,Inc recalls Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK7
Recalled March 26, 2014 · FDA recall Z-1266-2014 · Bock,Otto,Orthopedic Ind,Inc
Hazard
Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed. · FDA Class II
Units
464 units (US 113, OUS 351)
Sold at
Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Description
Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed.
Product
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.
Manufacturer(s)
Bock,Otto,Orthopedic Ind,Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →