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Megadyne Medical Product, Inc. is initiating a recall to update the Instructions for Use and product labeling to restrict use of the device to patients 12 years and older.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
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