The Recall Desk

FDA (Devices) recall action 71498

Allergan Inc recalled 2 products on 2015-07-29

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-07-29
Critical
0
Units
—

Why these products were recalled

Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.

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

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Devices)··2015-07-29

    Allergan Recalls Natrelle Tissue Expanders for Expired Shelf Life

    Allergan is recalling Natrelle CUI Series Tissue Expanders because the shipped products were beyond their shelf life. The recall involves 23 units total, with 16 distributed in the US.

    Product
    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 Tis
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2015-07-29

    Allergan Recalls Natrelle Tissue Expanders Due to Expired Shelf Life

    Allergan is recalling Natrelle 133 and CUI Series Tissue Expanders because the shipped products were beyond their 47-month shelf life.

    Product
    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.
    Category
    Distribution
    0 states