Z-0402-2016 Class II Terminated
FDA device recall Z-0402-2016 was initiated by Boston Scientific Corp on September 11, 2015 and is designated Class II. 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 cont… The recall status is terminated (terminated May 17, 2016). Affected quantity: 22 units.
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.