Events

Recall of NATRELLE 133 TISSUE EXPANDER WITH MAGNAFINDER XACT & 21G NEEDLE INFUSION SET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ALLERGAN INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    44419
  • Event Risk Class
    II
  • Event Initiated Date
    2015-06-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Allergan is recalling specific lots of natrelle 133 series tissue expanders because product was shipped beyond its 47-month shelf life.

Device

NATRELLE 133 TISSUE EXPANDER WITH MAGNAFINDER XACT & 21G NEEDLE INFUSION SET
  • Model / Serial
    Model Catalog: 133FV-13 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133FV-12 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-16 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-15 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-14 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-13 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-12 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133MV-11 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-16 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-15 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-14 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-13 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-12 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133LV-11 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133FV-16 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: 133FV-15 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog:
  • Product Description
    NATRELLE 133 SERIES TISSUE EXPANDERS
  • Manufacturer
    ALLERGAN INC.

Manufacturer

ALLERGAN INC.