Boston Scientific Corporation recalls EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer B
Recalled Product
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Hazard / Issue
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
Issued by
FDA
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