Allergan Inc recalls Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporar…

Recall date

June 18, 2015

Source

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

Recall number

Z-2104-2015

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 products shipped were beyond the 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 CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.