Reported Dec 16, 2015 · Terminated
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Boston Scientific Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corp · 780 Brookside Dr · Spencer, IN · 47460-1080
Is this the product you have?
- One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017 2 Material Number M00563080, Lot # 18179867, Exp. April 30, 2017 3 & Lot # 18212410 , Exp. May 31, 2017 4 Material Number M00568510, Lot # 18296155, Exp. May 31, 2018. - Amount recalled
- 22 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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