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.
Reason for recall: 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. Distribution: International distribution to the country of Japan only. Quantity: 0 US; 74 OUS Lot/code info: UPN M00509500, GTIN (UDI-DI) 08714729902713, Lot 31073152; UPN M00509510, GTIN (UDI-DI) 08714729902720, Lots 31221751, 31761882, 32409573.
08714729902713, 08714729902720
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.