FDA-Device2015-12-16Class II
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Boston Scientific Corp
Hazard
Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
Sold states
US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
Affected count
22 units
Manufactured in
780 Brookside Dr, N/A, Spencer, IN, United States
Products
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0402-2016Don't want to check this manually?
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