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FDANovember 6, 2019device

Natrelle Silicone Filled Breast Implants for the following Styles and Sizes: Style 10, Style 15, Style 20, Style 40, Style 45 Style 10/UDI: NATRELLE Style 10-180 Gel Round Mod 10888628001206, NATRELLE Style 10-210 Gel Round Mod 10888628001213, NATRELLE Style 10-240 Gel Round Mod 10888628001220, N...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The firm has became aware that 2D barcodes on breast implants and sizers may be unreadable by GS-1 configured scanners. These 2D barcodes contain a group separators between fixed-length element string in the UDI data chain of the 2D barcode, which is not formatted to the GS1 standard.

What to do

FDA enforcement status: Terminated

Brands named

allergan plcallergan

UPCs

108886280012061088862800121310888628001220108886280012371088862800124410888628001251108886280012681088862800127510888628001282108886280012991088862800131210888628001374

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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