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Boston Scientific Corp recalls One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Recalled December 16, 2015 · FDA recall Z-0402-2016 · Boston Scientific
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. · FDA Class II
Units
22 units
Sold at
US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
Description
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.
Product
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Manufacturer(s)
Boston Scientific Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →