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U.S. FDA labels J&J surgical staplers' recall as severest


Reuters

U.S. FDA labels J&J surgical staplers' recall as severest


May 17 (Reuters) - The U.S. Food and Drug Administration warned of risks of serious injury or death from surgical staplers made by Johnson & Johnson's Ethicon unit, labeling a recent recall of the device as its most serious.

The recall, initiated early April by Ethicon, covers 92,496 surgical staplers and is now labeled as "Class-1" - the strictest form of recall issued by FDA, where use of faulty devices may cause serious injury or death.

J&J's Ethicon unit confirmed serious injuries to two patients, related to the use of the recalled product, the FDA(graphic).

The FDA will hold an advisory committee meeting on May 30 to discuss whether reclassifying the staplers for internal use as Class II medical devices would be appropriate.

The reclassification would subject the staplers to premarket notification and allow the FDA to establish further regulation on the device.






This article appears in: World Markets , Stocks , Politics
Referenced Symbols: JNJ



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