Z-2732-2014 Class II Terminated

Recalled by Apollo Endosurgery Inc — West Lake Hills, TX

Recall Details

Product Type
Devices
Report Date
October 8, 2014
Initiation Date
August 15, 2014
Termination Date
February 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

Product Description

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.

Reason for Recall

Product was distributed past its expiration date.

Distribution Pattern

Distributed in the states of California, Delaware, Indiana, Missouri, New Jersey, New York, and Oregon.

Code Information

Lap-Band System AP Standard Catalog Number B-2240; Serial Numbers: 17760203, 17704664, 17704665, 17760205, 17760179, 17704672, 17704667, 17704659, 17760194, 17704653