Allergan Inc recalls Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcu…

Recall date

June 18, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2103-2015

FDA classification

Class II

Brand / firm

Allergan Inc

Sold / distributed

US in the state of Canada

Why it was recalled

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.