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FDAFDA · Food and drugs·Recall number Z-2732-2014

LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m2 or a BMI of at least 30 kg/m2 with one or more obesity related comorbid conditions.

Published October 8, 2014 · Recall initiated: August 15, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Product was distributed past its expiration date.

What to do

Voluntary: Firm initiated · Telephone

Recall details

Manufacturer
Apollo Endosurgery Inc
Distributor
Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.
Lot
Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653
Risk classification
Class II
Area (FDA)
device
Country
United States

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