Allergan

2015

• 18 Jun 2015 Z-2103-2015 Class II Terminated Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.via FDA establishment ALLERGAN
• 18 Jun 2015 Z-2104-2015 Class II Terminated Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.via FDA establishment ALLERGAN
• 8 Jun 2015 Z-1988-2015 Class II Terminated Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast Implant Sizer because the expired product was shipped to the user level.via FDA establishment ALLERGAN

2011

• 21 Mar 2011 Z-2123-2011 Unclassified (pre-2012) Terminated The recall was initiated because Allergan has determined that a number of Access Port Needle pouches from one specific lot number may have small gaps in a pouch seal. Consequently the product may no longer be sterile.via FDA establishment ALLERGAN

2010

• 16 Sep 2010 Z-0418-2011 Unclassified (pre-2012) Terminated In a LAP-BAND System adjustment, failure to inject the needle perpendicular to the access port septum, as described in Directions for Use, may lead to port damage, resulting in subsequent port leakage. Leakage results in deflation of the LAP-BAND to its widest, open position requiring a procedure to replace the port. The patient may have symptoms of reduced satiety and increased appetite. Stallingvia FDA establishment ALLERGAN