FDAJune 18, 2015device
Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
What to do
FDA enforcement status: Terminated
Brands named
allergan
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDANatrelle Saline-Filled Breast Implant, for the following Styles and sizes, Style LP, Style 68 HP, Style 68 MP, Style LP/UDI: NATRELLE Style 68LP-125 Saline Round Low 10888628000513, NATRELLE Style 68LP-150 Saline Round Low 10888628000520, NATRELLE Style 68LP-175 Saline Round Low 10888628000537, N...2019-11-06
- FDANATRELLE Resterilizable Sizers for the styles and sizes: Style 15, Style 20, Inspira X (responsive gel), Inspira F (responsive gel), Inspira LP (responsive gel), Inspira M (responsive gel), Inspira L (responsive gel), Inspira ST L (Soft Touch gel), Inspira ST LP (Soft Touch Gel), Inspira ST M (So...2019-11-06
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