Boston Scientific Corp recalls One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.

Recall date

September 11, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0402-2016

FDA classification

Class II

Brand / firm

Boston Scientific Corp

Sold / distributed

US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.