Recall Z-0402-2016— Boston Scientific Corp

Name: FDA recall Z-0402-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-11

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corp, initiated 2015-09-11, terminated 2016-05-17. It names one FDA 510(k) clearance: K910584. Product: One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.. Reason: 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..

Recalling firm: Boston Scientific Corp
Classification: Class II
Status: Terminated
Initiated: 2015-09-11
Terminated: 2016-05-17
Firm location: Spencer, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K910584 — ONE STEP BUTTON(TM)Applied Medical Technologies·cleared 1991-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.