Z-0402-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 16, 2015
- Initiation Date
- September 11, 2015
- Termination Date
- May 17, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
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.
Distribution Pattern
US Distribution to the states of : IN, NV, CA, PA, CT, TN, NY, WI, and WA, and Internationally to Ireland.
Code Information
Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018.