medical Class I Updated 2019-09-18

Allergan PLC recalls McGhan Croissant-Shaped Tissue Expanders, Style 134 Produ

Recalled Product

McGhan Croissant-Shaped Tissue Expanders, Style 134 Product Usage: intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.


Hazard / Issue

The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: ALL LOTS;
View official government recall

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