FDA-Device2015-07-29Class II
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.
Allergan Inc
Hazard
Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
Sold states
US in the state of Canada
Affected count
167 units total (114 units in US)
Manufactured in
2525 Dupont Dr, N/A, Irvine, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2015Don't want to check this manually?
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